Asthma

A recent alert posted on the Asthma and Allergy Foundation of America (AAFA) website blog announced, “Flovent HFA and Flovent Diskus Asthma Medicine Being Discontinued.” A further heading positioned next to images of the two red inhaler devices stated: “Generic versions of the same medicines and devices are available but you need to check your insurance.” While few, it is generally thought, will have trouble finding suitable alternatives, the warning captured the reality descending upon some individual asthma sufferers whose insurance coverage may need tweaking at the very least, or at worst may be lacking.

The AAFA blog included a GSK (GlaxoSmithKline) November 2023 statement to AAFA regarding the brand name FLOVENT discontinuation. It noted the launch of an authorized Flovent HFA (fluticasone propionate inhalation aerosol) generic in May 2022 and a planned (October 2023) launch of an authorized generic for Flovent Diskus (fluticasone propionate inhalation powder) as “part of our commitment to be ambitious for patients.” The GSK statement continues: “These GSK manufactured authorized generics will provide patients in the US with potentially lower cost alternatives of these medically important products. We recognize that patients have a number of options in the therapeutic area and therefore remain committed to ensuring the affordability of our medicines.”

GSK will continue to manufacture the authorized generics, but they will be distributed by Prasco LLC.
 

Medicaid Rebate Cap Removed

As a Forbes article on January 3, 2024, by Joshua Cohen (“New Medicaid Rebate Rule Causes Problems For Asthma Patients On Flovent”) points out, the Flovent January 1, 2024, discontinuation coincided with the removal of the Medicaid rebate cap (American Rescue Plan Medicaid Drug Rebate Program) targeting manufacturers who had previously raised medication prices at rates higher than the inflation rate. The Forbes story notes GoodRx data showing a 47% increase in Flovent price since 2014. The implication is that drug manufacturers could be forced to sell such a drug to Medicaid at a loss because of the rebate cap removal. An authorized generic introduced to the market at a lower price under a private label with no price history, however, would not be subject to the higher Medicaid rebates.

Motivation considerations aside, the fallout for patients may or may not include a lower cost alternative. The authorized generic versions of Flovent HFA and Flovent Diskus are identical to the branded products with respect to the drugs and the devices. The GSK statement expressed hope that most insurance plans will replace the brand name with the authorized generic. The possibility persists, however, that there may be some that do not — resulting in a need to find the right substitute and/or higher out-of-pocket costs.

“Even though some patients may experience some disruption initially in their prescriptions,” Diego J. Maselli, MD, professor and chief, division of pulmonary diseases and critical care, UT Health at San Antonio, Texas, said in an interview, “fortunately, there are quite a few alternatives, and we don’t anticipate significant problems. It will be a wrinkle for some of the patients with regard to coverage, but there are definitely many alternatives that can provide good enough treatment for them.”
 

Similar alternative inhalers?

The alternatives have their specific properties and qualities, but the vast majority of experts, Dr. Maselli said, consider them to be very similar.

For CAREMARK CVS, a major pharmaceutical benefits manager, the preferred Flovent substitute is Pulmicort Flexhaler, a dry-powder inhaler that contains budesonide rather than fluticasone. While Flovent HF is a metered dose inhaler with a propellant, the Pulmicort device contains budesonide as a dry powder and requires activation through inhalation, which can be problematic for young children, AAFA CEO Kenneth Mendez said in an interview. To address that issue, he said, CVS Caremark is covering the authorized fluticasone metered dose inhaler generic for children under 6 years old. “Those individuals 6 years and older with severe asthma who can’t breathe deeply enough to get the medicine into their lungs will have to work with their doctors to apply for a formulary exception. And that’s a complicated process,” Mr. Mendez observed. “And it can take some time,” he added.

Another key issue highlighted here, he emphasized, is “how complicated this system is.” The U.S. drug pricing ecosystem involves multiple manufacturers, pharmacy benefit managers, insurance companies and their various plans, and federal policies potentially creating situations that may reduce access to critical medicines for patients, Mr. Mendez said. “Some people will be scurrying and scrambling to try to get coverage. The scope of the impact is actually unknown, but we’re going to find out now. As a nonprofit, we monitor social media and we’re listening closely.”

AAFA’s further concern is the rising costs of asthma medications. “It’s the number one thing we hear about as a patient organization,” Mr. Mendez said. On January 9, 2024, AAFA issued a press release praising the previous day’s news item from the U.S. Senate Committee on Health, Education, Labor & Pensions (“Chairman Sanders, Baldwin, Luján, Markey Launch HELP Committee Investigation into Efforts by Pharmaceutical Companies to Manipulate the Price of Asthma Inhalers). In it, Senator Bernie Sanders pointed to the more than 12-fold higher cost in the United States compared with the United Kingdom for GSK’s inhaler combining fluticasone and a beta2 agonist. The Senate HELP Committee has sent letters to the CEOs of the four major inhaler manufacturers (AstraZeneca, Boehringer Ingelheim, GSK, and Teva), stating: “These prices force patients, especially the uninsured and underinsured, to ration doses or abandon their prescriptions altogether. The results are predictable and devastating.”
 

High costs of inhalers could lead to rationing

AAFA research, the AAFA press release states, confirms that when asthma medicine costs become a barrier to treatment, people with asthma ration or discontinue medication use. The release also includes Mr. Mendez’s plea for a broad national conversation. “We are hopeful the HELP Committee investigation will lead to a national conversation about asthma drug costs and produce action that breaks down barriers to affordable treatment for people with asthma. The bottom line is that cost drives access. We understand the barriers, now it is important to move toward solutions.”

AAFA’s blog advises that when an individual’s insurance plan does not cover the authorized generic and does not offer a formulary exception, other inhaler options include ArmonAir Digihaler and Arnuity Ellipta. Because these are not identical to the authorized generics, individuals should check with their doctors regarding available doses and inhaler types and, if necessary, request training on inhaler use.

“It is really important for people with asthma to continue their asthma control medicines, especially during respiratory illness season.” AAFA urges individuals with asthma who are currently Flovent users to check with their doctors or pharmacists about the best next steps for them.

A recent alert posted on the Asthma and Allergy Foundation of America (AAFA) website blog announced, “Flovent HFA and Flovent Diskus Asthma Medicine Being Discontinued.” A further heading positioned next to images of the two red inhaler devices stated: “Generic versions of the same medicines and devices are available but you need to check your insurance.” While few, it is generally thought, will have trouble finding suitable alternatives, the warning captured the reality descending upon some individual asthma sufferers whose insurance coverage may need tweaking at the very least, or at worst may be lacking.

The AAFA blog included a GSK (GlaxoSmithKline) November 2023 statement to AAFA regarding the brand name FLOVENT discontinuation. It noted the launch of an authorized Flovent HFA (fluticasone propionate inhalation aerosol) generic in May 2022 and a planned (October 2023) launch of an authorized generic for Flovent Diskus (fluticasone propionate inhalation powder) as “part of our commitment to be ambitious for patients.” The GSK statement continues: “These GSK manufactured authorized generics will provide patients in the US with potentially lower cost alternatives of these medically important products. We recognize that patients have a number of options in the therapeutic area and therefore remain committed to ensuring the affordability of our medicines.”

GSK will continue to manufacture the authorized generics, but they will be distributed by Prasco LLC.
 

Medicaid Rebate Cap Removed

As a Forbes article on January 3, 2024, by Joshua Cohen (“New Medicaid Rebate Rule Causes Problems For Asthma Patients On Flovent”) points out, the Flovent January 1, 2024, discontinuation coincided with the removal of the Medicaid rebate cap (American Rescue Plan Medicaid Drug Rebate Program) targeting manufacturers who had previously raised medication prices at rates higher than the inflation rate. The Forbes story notes GoodRx data showing a 47% increase in Flovent price since 2014. The implication is that drug manufacturers could be forced to sell such a drug to Medicaid at a loss because of the rebate cap removal. An authorized generic introduced to the market at a lower price under a private label with no price history, however, would not be subject to the higher Medicaid rebates.

Motivation considerations aside, the fallout for patients may or may not include a lower cost alternative. The authorized generic versions of Flovent HFA and Flovent Diskus are identical to the branded products with respect to the drugs and the devices. The GSK statement expressed hope that most insurance plans will replace the brand name with the authorized generic. The possibility persists, however, that there may be some that do not — resulting in a need to find the right substitute and/or higher out-of-pocket costs.

“Even though some patients may experience some disruption initially in their prescriptions,” Diego J. Maselli, MD, professor and chief, division of pulmonary diseases and critical care, UT Health at San Antonio, Texas, said in an interview, “fortunately, there are quite a few alternatives, and we don’t anticipate significant problems. It will be a wrinkle for some of the patients with regard to coverage, but there are definitely many alternatives that can provide good enough treatment for them.”
 

Similar alternative inhalers?

The alternatives have their specific properties and qualities, but the vast majority of experts, Dr. Maselli said, consider them to be very similar.

For CAREMARK CVS, a major pharmaceutical benefits manager, the preferred Flovent substitute is Pulmicort Flexhaler, a dry-powder inhaler that contains budesonide rather than fluticasone. While Flovent HF is a metered dose inhaler with a propellant, the Pulmicort device contains budesonide as a dry powder and requires activation through inhalation, which can be problematic for young children, AAFA CEO Kenneth Mendez said in an interview. To address that issue, he said, CVS Caremark is covering the authorized fluticasone metered dose inhaler generic for children under 6 years old. “Those individuals 6 years and older with severe asthma who can’t breathe deeply enough to get the medicine into their lungs will have to work with their doctors to apply for a formulary exception. And that’s a complicated process,” Mr. Mendez observed. “And it can take some time,” he added.

Another key issue highlighted here, he emphasized, is “how complicated this system is.” The U.S. drug pricing ecosystem involves multiple manufacturers, pharmacy benefit managers, insurance companies and their various plans, and federal policies potentially creating situations that may reduce access to critical medicines for patients, Mr. Mendez said. “Some people will be scurrying and scrambling to try to get coverage. The scope of the impact is actually unknown, but we’re going to find out now. As a nonprofit, we monitor social media and we’re listening closely.”

AAFA’s further concern is the rising costs of asthma medications. “It’s the number one thing we hear about as a patient organization,” Mr. Mendez said. On January 9, 2024, AAFA issued a press release praising the previous day’s news item from the U.S. Senate Committee on Health, Education, Labor & Pensions (“Chairman Sanders, Baldwin, Luján, Markey Launch HELP Committee Investigation into Efforts by Pharmaceutical Companies to Manipulate the Price of Asthma Inhalers). In it, Senator Bernie Sanders pointed to the more than 12-fold higher cost in the United States compared with the United Kingdom for GSK’s inhaler combining fluticasone and a beta2 agonist. The Senate HELP Committee has sent letters to the CEOs of the four major inhaler manufacturers (AstraZeneca, Boehringer Ingelheim, GSK, and Teva), stating: “These prices force patients, especially the uninsured and underinsured, to ration doses or abandon their prescriptions altogether. The results are predictable and devastating.”
 

High costs of inhalers could lead to rationing

AAFA research, the AAFA press release states, confirms that when asthma medicine costs become a barrier to treatment, people with asthma ration or discontinue medication use. The release also includes Mr. Mendez’s plea for a broad national conversation. “We are hopeful the HELP Committee investigation will lead to a national conversation about asthma drug costs and produce action that breaks down barriers to affordable treatment for people with asthma. The bottom line is that cost drives access. We understand the barriers, now it is important to move toward solutions.”

AAFA’s blog advises that when an individual’s insurance plan does not cover the authorized generic and does not offer a formulary exception, other inhaler options include ArmonAir Digihaler and Arnuity Ellipta. Because these are not identical to the authorized generics, individuals should check with their doctors regarding available doses and inhaler types and, if necessary, request training on inhaler use.

“It is really important for people with asthma to continue their asthma control medicines, especially during respiratory illness season.” AAFA urges individuals with asthma who are currently Flovent users to check with their doctors or pharmacists about the best next steps for them.

A recent alert posted on the Asthma and Allergy Foundation of America (AAFA) website blog announced, “Flovent HFA and Flovent Diskus Asthma Medicine Being Discontinued.” A further heading positioned next to images of the two red inhaler devices stated: “Generic versions of the same medicines and devices are available but you need to check your insurance.” While few, it is generally thought, will have trouble finding suitable alternatives, the warning captured the reality descending upon some individual asthma sufferers whose insurance coverage may need tweaking at the very least, or at worst may be lacking.

The AAFA blog included a GSK (GlaxoSmithKline) November 2023 statement to AAFA regarding the brand name FLOVENT discontinuation. It noted the launch of an authorized Flovent HFA (fluticasone propionate inhalation aerosol) generic in May 2022 and a planned (October 2023) launch of an authorized generic for Flovent Diskus (fluticasone propionate inhalation powder) as “part of our commitment to be ambitious for patients.” The GSK statement continues: “These GSK manufactured authorized generics will provide patients in the US with potentially lower cost alternatives of these medically important products. We recognize that patients have a number of options in the therapeutic area and therefore remain committed to ensuring the affordability of our medicines.”

GSK will continue to manufacture the authorized generics, but they will be distributed by Prasco LLC.
 

Medicaid Rebate Cap Removed

As a Forbes article on January 3, 2024, by Joshua Cohen (“New Medicaid Rebate Rule Causes Problems For Asthma Patients On Flovent”) points out, the Flovent January 1, 2024, discontinuation coincided with the removal of the Medicaid rebate cap (American Rescue Plan Medicaid Drug Rebate Program) targeting manufacturers who had previously raised medication prices at rates higher than the inflation rate. The Forbes story notes GoodRx data showing a 47% increase in Flovent price since 2014. The implication is that drug manufacturers could be forced to sell such a drug to Medicaid at a loss because of the rebate cap removal. An authorized generic introduced to the market at a lower price under a private label with no price history, however, would not be subject to the higher Medicaid rebates.

Motivation considerations aside, the fallout for patients may or may not include a lower cost alternative. The authorized generic versions of Flovent HFA and Flovent Diskus are identical to the branded products with respect to the drugs and the devices. The GSK statement expressed hope that most insurance plans will replace the brand name with the authorized generic. The possibility persists, however, that there may be some that do not — resulting in a need to find the right substitute and/or higher out-of-pocket costs.

“Even though some patients may experience some disruption initially in their prescriptions,” Diego J. Maselli, MD, professor and chief, division of pulmonary diseases and critical care, UT Health at San Antonio, Texas, said in an interview, “fortunately, there are quite a few alternatives, and we don’t anticipate significant problems. It will be a wrinkle for some of the patients with regard to coverage, but there are definitely many alternatives that can provide good enough treatment for them.”
 

Similar alternative inhalers?

The alternatives have their specific properties and qualities, but the vast majority of experts, Dr. Maselli said, consider them to be very similar.

For CAREMARK CVS, a major pharmaceutical benefits manager, the preferred Flovent substitute is Pulmicort Flexhaler, a dry-powder inhaler that contains budesonide rather than fluticasone. While Flovent HF is a metered dose inhaler with a propellant, the Pulmicort device contains budesonide as a dry powder and requires activation through inhalation, which can be problematic for young children, AAFA CEO Kenneth Mendez said in an interview. To address that issue, he said, CVS Caremark is covering the authorized fluticasone metered dose inhaler generic for children under 6 years old. “Those individuals 6 years and older with severe asthma who can’t breathe deeply enough to get the medicine into their lungs will have to work with their doctors to apply for a formulary exception. And that’s a complicated process,” Mr. Mendez observed. “And it can take some time,” he added.

Another key issue highlighted here, he emphasized, is “how complicated this system is.” The U.S. drug pricing ecosystem involves multiple manufacturers, pharmacy benefit managers, insurance companies and their various plans, and federal policies potentially creating situations that may reduce access to critical medicines for patients, Mr. Mendez said. “Some people will be scurrying and scrambling to try to get coverage. The scope of the impact is actually unknown, but we’re going to find out now. As a nonprofit, we monitor social media and we’re listening closely.”

AAFA’s further concern is the rising costs of asthma medications. “It’s the number one thing we hear about as a patient organization,” Mr. Mendez said. On January 9, 2024, AAFA issued a press release praising the previous day’s news item from the U.S. Senate Committee on Health, Education, Labor & Pensions (“Chairman Sanders, Baldwin, Luján, Markey Launch HELP Committee Investigation into Efforts by Pharmaceutical Companies to Manipulate the Price of Asthma Inhalers). In it, Senator Bernie Sanders pointed to the more than 12-fold higher cost in the United States compared with the United Kingdom for GSK’s inhaler combining fluticasone and a beta2 agonist. The Senate HELP Committee has sent letters to the CEOs of the four major inhaler manufacturers (AstraZeneca, Boehringer Ingelheim, GSK, and Teva), stating: “These prices force patients, especially the uninsured and underinsured, to ration doses or abandon their prescriptions altogether. The results are predictable and devastating.”
 

High costs of inhalers could lead to rationing

AAFA research, the AAFA press release states, confirms that when asthma medicine costs become a barrier to treatment, people with asthma ration or discontinue medication use. The release also includes Mr. Mendez’s plea for a broad national conversation. “We are hopeful the HELP Committee investigation will lead to a national conversation about asthma drug costs and produce action that breaks down barriers to affordable treatment for people with asthma. The bottom line is that cost drives access. We understand the barriers, now it is important to move toward solutions.”

AAFA’s blog advises that when an individual’s insurance plan does not cover the authorized generic and does not offer a formulary exception, other inhaler options include ArmonAir Digihaler and Arnuity Ellipta. Because these are not identical to the authorized generics, individuals should check with their doctors regarding available doses and inhaler types and, if necessary, request training on inhaler use.

“It is really important for people with asthma to continue their asthma control medicines, especially during respiratory illness season.” AAFA urges individuals with asthma who are currently Flovent users to check with their doctors or pharmacists about the best next steps for them.

The impact of maternal factors on allergy and asthma is the subject of new research in the wake of a grant from the National Institute of Allergy and Infectious Diseases to a team at Indiana University School of Medicine, according to a university press release.

Researchers led by Joan Cook-Mills, PhD, will examine the mechanisms behind the development of asthma, food allergies, and allergic diseases in children whose mothers had allergies.

“Research from the Cook-Mills lab revealed mothers with allergies have elevated levels of a specific lipid within the eicosanoid class of lipids, suggesting this lipid may have a potential influence on their offspring also developing allergies,” according to the press release.

A 5-year grant for $3.9 million was awarded to extend work by the Cook-Mills lab, and the research will focus on four areas, according to the university:

The potential impact of higher levels of lipid from mothers’ lungs may affect infants’ risk for allergy and whether this lipid is transmitted to infants during pregnancy or breastfeeding.

The potential impact of elevated levels of a specific eicosanoid in mothers with allergies promotes the creation of more dendritic cells by fetal bone marrow and how this might affect allergy risk for infants.

The potential impact of elevated eicosanoids in allergic mothers can affect the lung microbiome in mothers and their offspring, potentially leading to altered lung bacteria, which can affect immune cell responses to allergies and asthma.

The potential impact of elevated eicosanoids on whether the altered lung microbiome “actively changes the production of this eicosanoid in the lungs of allergic mothers,” according to the press release.

“Allergies and asthma cause a significant burden of disease in our pediatric population, which is further complicated by limited therapies and interventions to combat these diseases, let alone prevent their development,” Anne C. Coates, MD, a pediatric pulmonologist at Maine Medical Center, Portland, said in an interview.

“The work by Cook-Mills and her colleagues will expand our understanding of the role maternal health may have on allergies and asthma and opportunities to mitigate it,” she said. The key implications of the research are the potential to facilitate the development of future clinical studies and trials that could yield novel targeted treatments for significant allergies, Dr. Coates told this news organization.

The research by Cook-Mills and her team had “the potential for the development of transformative approaches to allergy prevention and management, which could improve the health and quality of life for scores of individuals worldwide,” she said.

Dr. Coates had no financial conflicts to disclose but served on the Editorial Advisory Board of Chest Physician.

A version of this article appeared on Medscape.com.

The impact of maternal factors on allergy and asthma is the subject of new research in the wake of a grant from the National Institute of Allergy and Infectious Diseases to a team at Indiana University School of Medicine, according to a university press release.

Researchers led by Joan Cook-Mills, PhD, will examine the mechanisms behind the development of asthma, food allergies, and allergic diseases in children whose mothers had allergies.

“Research from the Cook-Mills lab revealed mothers with allergies have elevated levels of a specific lipid within the eicosanoid class of lipids, suggesting this lipid may have a potential influence on their offspring also developing allergies,” according to the press release.

A 5-year grant for $3.9 million was awarded to extend work by the Cook-Mills lab, and the research will focus on four areas, according to the university:

The potential impact of higher levels of lipid from mothers’ lungs may affect infants’ risk for allergy and whether this lipid is transmitted to infants during pregnancy or breastfeeding.

The potential impact of elevated levels of a specific eicosanoid in mothers with allergies promotes the creation of more dendritic cells by fetal bone marrow and how this might affect allergy risk for infants.

The potential impact of elevated eicosanoids in allergic mothers can affect the lung microbiome in mothers and their offspring, potentially leading to altered lung bacteria, which can affect immune cell responses to allergies and asthma.

The potential impact of elevated eicosanoids on whether the altered lung microbiome “actively changes the production of this eicosanoid in the lungs of allergic mothers,” according to the press release.

“Allergies and asthma cause a significant burden of disease in our pediatric population, which is further complicated by limited therapies and interventions to combat these diseases, let alone prevent their development,” Anne C. Coates, MD, a pediatric pulmonologist at Maine Medical Center, Portland, said in an interview.

“The work by Cook-Mills and her colleagues will expand our understanding of the role maternal health may have on allergies and asthma and opportunities to mitigate it,” she said. The key implications of the research are the potential to facilitate the development of future clinical studies and trials that could yield novel targeted treatments for significant allergies, Dr. Coates told this news organization.

The research by Cook-Mills and her team had “the potential for the development of transformative approaches to allergy prevention and management, which could improve the health and quality of life for scores of individuals worldwide,” she said.

Dr. Coates had no financial conflicts to disclose but served on the Editorial Advisory Board of Chest Physician.

A version of this article appeared on Medscape.com.

The impact of maternal factors on allergy and asthma is the subject of new research in the wake of a grant from the National Institute of Allergy and Infectious Diseases to a team at Indiana University School of Medicine, according to a university press release.

Researchers led by Joan Cook-Mills, PhD, will examine the mechanisms behind the development of asthma, food allergies, and allergic diseases in children whose mothers had allergies.

“Research from the Cook-Mills lab revealed mothers with allergies have elevated levels of a specific lipid within the eicosanoid class of lipids, suggesting this lipid may have a potential influence on their offspring also developing allergies,” according to the press release.

A 5-year grant for $3.9 million was awarded to extend work by the Cook-Mills lab, and the research will focus on four areas, according to the university:

The potential impact of higher levels of lipid from mothers’ lungs may affect infants’ risk for allergy and whether this lipid is transmitted to infants during pregnancy or breastfeeding.

The potential impact of elevated levels of a specific eicosanoid in mothers with allergies promotes the creation of more dendritic cells by fetal bone marrow and how this might affect allergy risk for infants.

The potential impact of elevated eicosanoids in allergic mothers can affect the lung microbiome in mothers and their offspring, potentially leading to altered lung bacteria, which can affect immune cell responses to allergies and asthma.

The potential impact of elevated eicosanoids on whether the altered lung microbiome “actively changes the production of this eicosanoid in the lungs of allergic mothers,” according to the press release.

“Allergies and asthma cause a significant burden of disease in our pediatric population, which is further complicated by limited therapies and interventions to combat these diseases, let alone prevent their development,” Anne C. Coates, MD, a pediatric pulmonologist at Maine Medical Center, Portland, said in an interview.

“The work by Cook-Mills and her colleagues will expand our understanding of the role maternal health may have on allergies and asthma and opportunities to mitigate it,” she said. The key implications of the research are the potential to facilitate the development of future clinical studies and trials that could yield novel targeted treatments for significant allergies, Dr. Coates told this news organization.

The research by Cook-Mills and her team had “the potential for the development of transformative approaches to allergy prevention and management, which could improve the health and quality of life for scores of individuals worldwide,” she said.

Dr. Coates had no financial conflicts to disclose but served on the Editorial Advisory Board of Chest Physician.

A version of this article appeared on Medscape.com.

Can asthma symptoms be monitored reliably at home? Until now, the answer would have been yes, but not in preschool-age patients. Recent findings in Annals of Family Medicine suggest that this limitation can be overcome with the assistance of artificial intelligence (AI). The use of an AI-assisted stethoscope can generate reliable data, even in young children, thus providing caregivers with information about asthma exacerbations.

Objectivity Challenge

A timely diagnosis of asthma exacerbations, which is crucial for proper disease management, requires effective home monitoring. While some lung function parameters, like peak expiratory flow (PEF), can be measured by patients at home, tools for this purpose are not designed for very young children.

“To achieve effective asthma management, patients should be given the necessary tools to allow them to recognize and respond to worsening asthma,” wrote the study authors. Despite the Global Initiative for Asthma identifying respiratory sounds as a fundamental parameter for exacerbation recognition, these are almost exclusively evaluated during doctor visits. Recognizing respiratory sounds and judging whether there has been a change can be challenging for those outside the medical profession.

To enhance home monitoring, researchers from the Department of Pediatric Pneumology and Rheumatology at the University of Lublin, Poland, experimented with the StethoMe stethoscope, which enables the recognition of pathologic signs, including continuous and transient noises. This AI-assisted stethoscope, trained on over 10,000 respiratory sound recordings, is certified as a Class IIa medical device in Europe.
 

The ‘Smart’ Stethoscope

The 6-month study enlisted 149 patients with asthma (90 children and 59 adults). Participants self-monitored (but parents or caregivers managed for children) once daily in the first 2 weeks and at least once weekly thereafter using three tools. The first was the StethoMe stethoscope, which was used for detecting respiratory sounds, respiratory rate (RR), heart rate (HR), and inspiration/expiration ratio (I/E). Patients were provided a “map” of chest points at which to position the stethoscope. The second was a pulse oximeter, which was used to measure oxygen saturation. The third was a peak flow meter for quantifying PEF. Simultaneously, a health questionnaire was completed.

Data from 6029 completed self-monitoring sessions were used to determine the most effective parameter for exacerbation recognition, quantified by the area under the receiver operating characteristic curve (AUC). The researchers concluded that the parameter with the best performance was wheeze intensity in young children (AUC 84%, 95% CI, 82%-85%), wheeze intensity in older children (AUC, 81%; 95% CI, 79%-84%), and questionnaire response for adults (AUC, 92%; 95% CI, 89%-95%). Combining multiple parameters increased effectiveness.

“The present results clearly show that a set of parameters (wheezes, rhonchi, coarse and fine crackles, HR, RR, and I/E) measured by a device such as an AI-aided home stethoscope allows for the detection of exacerbations without the need for performing PEF measurements, which can be equivocal,” the study authors concluded. “In addition, in the case of younger children (age, < 5 years), when introduced on a large scale, the analyzed home stethoscope appears to be a promising tool that might make asthma diagnosis more straightforward and substantially facilitate asthma monitoring.”

A version of this article first appeared on Medscape.com. This article was translated from Univadis Italy, which is part of the Medscape professional network.

Can asthma symptoms be monitored reliably at home? Until now, the answer would have been yes, but not in preschool-age patients. Recent findings in Annals of Family Medicine suggest that this limitation can be overcome with the assistance of artificial intelligence (AI). The use of an AI-assisted stethoscope can generate reliable data, even in young children, thus providing caregivers with information about asthma exacerbations.

Objectivity Challenge

A timely diagnosis of asthma exacerbations, which is crucial for proper disease management, requires effective home monitoring. While some lung function parameters, like peak expiratory flow (PEF), can be measured by patients at home, tools for this purpose are not designed for very young children.

“To achieve effective asthma management, patients should be given the necessary tools to allow them to recognize and respond to worsening asthma,” wrote the study authors. Despite the Global Initiative for Asthma identifying respiratory sounds as a fundamental parameter for exacerbation recognition, these are almost exclusively evaluated during doctor visits. Recognizing respiratory sounds and judging whether there has been a change can be challenging for those outside the medical profession.

To enhance home monitoring, researchers from the Department of Pediatric Pneumology and Rheumatology at the University of Lublin, Poland, experimented with the StethoMe stethoscope, which enables the recognition of pathologic signs, including continuous and transient noises. This AI-assisted stethoscope, trained on over 10,000 respiratory sound recordings, is certified as a Class IIa medical device in Europe.
 

The ‘Smart’ Stethoscope

The 6-month study enlisted 149 patients with asthma (90 children and 59 adults). Participants self-monitored (but parents or caregivers managed for children) once daily in the first 2 weeks and at least once weekly thereafter using three tools. The first was the StethoMe stethoscope, which was used for detecting respiratory sounds, respiratory rate (RR), heart rate (HR), and inspiration/expiration ratio (I/E). Patients were provided a “map” of chest points at which to position the stethoscope. The second was a pulse oximeter, which was used to measure oxygen saturation. The third was a peak flow meter for quantifying PEF. Simultaneously, a health questionnaire was completed.

Data from 6029 completed self-monitoring sessions were used to determine the most effective parameter for exacerbation recognition, quantified by the area under the receiver operating characteristic curve (AUC). The researchers concluded that the parameter with the best performance was wheeze intensity in young children (AUC 84%, 95% CI, 82%-85%), wheeze intensity in older children (AUC, 81%; 95% CI, 79%-84%), and questionnaire response for adults (AUC, 92%; 95% CI, 89%-95%). Combining multiple parameters increased effectiveness.

“The present results clearly show that a set of parameters (wheezes, rhonchi, coarse and fine crackles, HR, RR, and I/E) measured by a device such as an AI-aided home stethoscope allows for the detection of exacerbations without the need for performing PEF measurements, which can be equivocal,” the study authors concluded. “In addition, in the case of younger children (age, < 5 years), when introduced on a large scale, the analyzed home stethoscope appears to be a promising tool that might make asthma diagnosis more straightforward and substantially facilitate asthma monitoring.”

A version of this article first appeared on Medscape.com. This article was translated from Univadis Italy, which is part of the Medscape professional network.

Can asthma symptoms be monitored reliably at home? Until now, the answer would have been yes, but not in preschool-age patients. Recent findings in Annals of Family Medicine suggest that this limitation can be overcome with the assistance of artificial intelligence (AI). The use of an AI-assisted stethoscope can generate reliable data, even in young children, thus providing caregivers with information about asthma exacerbations.

Objectivity Challenge

A timely diagnosis of asthma exacerbations, which is crucial for proper disease management, requires effective home monitoring. While some lung function parameters, like peak expiratory flow (PEF), can be measured by patients at home, tools for this purpose are not designed for very young children.

“To achieve effective asthma management, patients should be given the necessary tools to allow them to recognize and respond to worsening asthma,” wrote the study authors. Despite the Global Initiative for Asthma identifying respiratory sounds as a fundamental parameter for exacerbation recognition, these are almost exclusively evaluated during doctor visits. Recognizing respiratory sounds and judging whether there has been a change can be challenging for those outside the medical profession.

To enhance home monitoring, researchers from the Department of Pediatric Pneumology and Rheumatology at the University of Lublin, Poland, experimented with the StethoMe stethoscope, which enables the recognition of pathologic signs, including continuous and transient noises. This AI-assisted stethoscope, trained on over 10,000 respiratory sound recordings, is certified as a Class IIa medical device in Europe.
 

The ‘Smart’ Stethoscope

The 6-month study enlisted 149 patients with asthma (90 children and 59 adults). Participants self-monitored (but parents or caregivers managed for children) once daily in the first 2 weeks and at least once weekly thereafter using three tools. The first was the StethoMe stethoscope, which was used for detecting respiratory sounds, respiratory rate (RR), heart rate (HR), and inspiration/expiration ratio (I/E). Patients were provided a “map” of chest points at which to position the stethoscope. The second was a pulse oximeter, which was used to measure oxygen saturation. The third was a peak flow meter for quantifying PEF. Simultaneously, a health questionnaire was completed.

Data from 6029 completed self-monitoring sessions were used to determine the most effective parameter for exacerbation recognition, quantified by the area under the receiver operating characteristic curve (AUC). The researchers concluded that the parameter with the best performance was wheeze intensity in young children (AUC 84%, 95% CI, 82%-85%), wheeze intensity in older children (AUC, 81%; 95% CI, 79%-84%), and questionnaire response for adults (AUC, 92%; 95% CI, 89%-95%). Combining multiple parameters increased effectiveness.

“The present results clearly show that a set of parameters (wheezes, rhonchi, coarse and fine crackles, HR, RR, and I/E) measured by a device such as an AI-aided home stethoscope allows for the detection of exacerbations without the need for performing PEF measurements, which can be equivocal,” the study authors concluded. “In addition, in the case of younger children (age, < 5 years), when introduced on a large scale, the analyzed home stethoscope appears to be a promising tool that might make asthma diagnosis more straightforward and substantially facilitate asthma monitoring.”

A version of this article first appeared on Medscape.com. This article was translated from Univadis Italy, which is part of the Medscape professional network.

Sabine Roman, MD, PhD, associate professor of gastroenterology and physiology at Lyon University Hospital in France, took the floor at the United European Gastroenterology Week to discuss the link between a chronic cough and gastroesophageal reflux disease (GERD). During a session on extraesophageal symptoms, Dr. Roman relayed two key messages: In patients with a chronic cough, reflux absolutely must be documented, and proton pump inhibitors (PPIs) must only be prescribed when a diagnosis of GERD has been made.
 

Overestimated Cause

Chronic cough is a widespread problem with a prevalence of between 9% and 33%, according to clinical studies. The root causes of this cough are varied; they’re mainly related to the respiratory system (eg, asthma, chronic obstructive pulmonary disease, respiratory infections, or smoking) and the ear, nose, and throat field (eg, postnasal drip). What’s more, taking certain medicines, notably angiotensin-converting enzyme inhibitors, can also be at the root of this condition.

GERD is also a possible cause of a chronic cough but one that is likely overestimated. A 2023 Spanish study provides evidence of this; GERD was suspected to be linked to cough in 46% of patients (compared with 32% for asthma and 15% for postnasal drip).

The treatments most commonly prescribed include PPIs (79.6%) and respiratory medicines (87.8%). Note that antibiotics are administered empirically to 28.6% of patients. For Roman, “the blame for a chronic cough is too often assigned to GERD, especially considering that in this study, only 43% of patients had seen a gastroenterologist, 27% had an endoscopy, and 24% had undergone esophageal pH monitoring.”

Added to this observation is the difficulty of establishing a causal link between a cough and GERD when the latter is present, even when the patient has had a diagnosis of GERD. Of course, a link between the two does not necessarily imply a cause–effect relationship, especially given that studies have shown that a cough itself can induce GERD. Studies using automatic cough detection to count cough events have shown that GERD certainly preceded a cough in 48% of patients, but in 56% of cases, it was the cough that came before the GERD. What’s more, both mechanisms were present in one third of patients.
 

Prescribing PPIs Effectively

PPIs are commonly prescribed as a test treatment. However, their efficacy is in no way proof of the existence of underlying GERD. In reality, all placebo-controlled studies have shown that in cases where no prior diagnosis of GERD has been made, PPIs have no superior efficacy.

If reflux has been proven, then the improvement provided by PPIs, compared with placebo, is between 12% and 35%. Therefore, it is essential that the presence of GERD be demonstrated, particularly if the patient has no characteristic symptoms of GERD, such as heartburn and acid reflux.

Response factors to PPIs were evaluated in 178 Italian patients with a chronic cough who presented with suspected GERD. Of those, 45% responded to treatment. It has been shown that typical symptoms, severe esophagitis (grade C/D), abnormal acid exposure, and low levels of nocturnal baseline impedance were independent factors of response to treatment.

In conclusion, patients with a chronic cough must be comprehensively tested for GERD before a long-term prescription of PPIs can be considered.
 

Cough Reflex Threshold

Various studies have also revealed that patients with GERD and presenting with a chronic cough have an increased sensitivity to the cough reflex. This hypersensitivity to the cough reflex has inspired several trials involving gabapentin and baclofen. A randomized controlled trial found the two treatments to be equally effective, achieving improvement of around 50%.

Lesogaberan, a new GABA(B) receptor agonist acting on the peripheral nervous system which is better tolerated than baclofen, a drug belonging to the same therapeutic class, showed a 26% benefit over placebo, but it was not statistically significant; lesogaberan has not been developed further.

Anti-reflux surgery is an option. A 2021 meta-analysis revealed that 84% of patients enrolled in these studies saw an improvement in their symptoms. However, these results must be regarded with caution because none of these studies were controlled, most of them were retrospective with very heterogeneous patient populations, and the data obtained on postoperative reflux control were often found to be lacking.

A retrospective study showed that among the factors for nonresponse or recurrence of symptoms after anti-reflux surgery, lack of response to medical treatment and extraesophageal symptoms such as a cough were significant factors. Consequently, potential candidates for surgery must be rigorously screened before being considered for such a procedure.

The recent recommendations for good practice published by the American Gastroenterological Association also insist that lack of response to medical treatment is a major factor for failure of surgical treatment.

In sum, patients with a chronic cough can be prescribed PPIs as first-line treatment if they have typical symptoms of GERD. In the event of treatment failure or isolated cough without typical symptoms, tests to confirm or rule out GERD are essential (such as endoscopy, esophageal pH monitoring, or impedance-pH monitoring).
 

This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.

Sabine Roman, MD, PhD, associate professor of gastroenterology and physiology at Lyon University Hospital in France, took the floor at the United European Gastroenterology Week to discuss the link between a chronic cough and gastroesophageal reflux disease (GERD). During a session on extraesophageal symptoms, Dr. Roman relayed two key messages: In patients with a chronic cough, reflux absolutely must be documented, and proton pump inhibitors (PPIs) must only be prescribed when a diagnosis of GERD has been made.
 

Overestimated Cause

Chronic cough is a widespread problem with a prevalence of between 9% and 33%, according to clinical studies. The root causes of this cough are varied; they’re mainly related to the respiratory system (eg, asthma, chronic obstructive pulmonary disease, respiratory infections, or smoking) and the ear, nose, and throat field (eg, postnasal drip). What’s more, taking certain medicines, notably angiotensin-converting enzyme inhibitors, can also be at the root of this condition.

GERD is also a possible cause of a chronic cough but one that is likely overestimated. A 2023 Spanish study provides evidence of this; GERD was suspected to be linked to cough in 46% of patients (compared with 32% for asthma and 15% for postnasal drip).

The treatments most commonly prescribed include PPIs (79.6%) and respiratory medicines (87.8%). Note that antibiotics are administered empirically to 28.6% of patients. For Roman, “the blame for a chronic cough is too often assigned to GERD, especially considering that in this study, only 43% of patients had seen a gastroenterologist, 27% had an endoscopy, and 24% had undergone esophageal pH monitoring.”

Added to this observation is the difficulty of establishing a causal link between a cough and GERD when the latter is present, even when the patient has had a diagnosis of GERD. Of course, a link between the two does not necessarily imply a cause–effect relationship, especially given that studies have shown that a cough itself can induce GERD. Studies using automatic cough detection to count cough events have shown that GERD certainly preceded a cough in 48% of patients, but in 56% of cases, it was the cough that came before the GERD. What’s more, both mechanisms were present in one third of patients.
 

Prescribing PPIs Effectively

PPIs are commonly prescribed as a test treatment. However, their efficacy is in no way proof of the existence of underlying GERD. In reality, all placebo-controlled studies have shown that in cases where no prior diagnosis of GERD has been made, PPIs have no superior efficacy.

If reflux has been proven, then the improvement provided by PPIs, compared with placebo, is between 12% and 35%. Therefore, it is essential that the presence of GERD be demonstrated, particularly if the patient has no characteristic symptoms of GERD, such as heartburn and acid reflux.

Response factors to PPIs were evaluated in 178 Italian patients with a chronic cough who presented with suspected GERD. Of those, 45% responded to treatment. It has been shown that typical symptoms, severe esophagitis (grade C/D), abnormal acid exposure, and low levels of nocturnal baseline impedance were independent factors of response to treatment.

In conclusion, patients with a chronic cough must be comprehensively tested for GERD before a long-term prescription of PPIs can be considered.
 

Cough Reflex Threshold

Various studies have also revealed that patients with GERD and presenting with a chronic cough have an increased sensitivity to the cough reflex. This hypersensitivity to the cough reflex has inspired several trials involving gabapentin and baclofen. A randomized controlled trial found the two treatments to be equally effective, achieving improvement of around 50%.

Lesogaberan, a new GABA(B) receptor agonist acting on the peripheral nervous system which is better tolerated than baclofen, a drug belonging to the same therapeutic class, showed a 26% benefit over placebo, but it was not statistically significant; lesogaberan has not been developed further.

Anti-reflux surgery is an option. A 2021 meta-analysis revealed that 84% of patients enrolled in these studies saw an improvement in their symptoms. However, these results must be regarded with caution because none of these studies were controlled, most of them were retrospective with very heterogeneous patient populations, and the data obtained on postoperative reflux control were often found to be lacking.

A retrospective study showed that among the factors for nonresponse or recurrence of symptoms after anti-reflux surgery, lack of response to medical treatment and extraesophageal symptoms such as a cough were significant factors. Consequently, potential candidates for surgery must be rigorously screened before being considered for such a procedure.

The recent recommendations for good practice published by the American Gastroenterological Association also insist that lack of response to medical treatment is a major factor for failure of surgical treatment.

In sum, patients with a chronic cough can be prescribed PPIs as first-line treatment if they have typical symptoms of GERD. In the event of treatment failure or isolated cough without typical symptoms, tests to confirm or rule out GERD are essential (such as endoscopy, esophageal pH monitoring, or impedance-pH monitoring).
 

This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.

Sabine Roman, MD, PhD, associate professor of gastroenterology and physiology at Lyon University Hospital in France, took the floor at the United European Gastroenterology Week to discuss the link between a chronic cough and gastroesophageal reflux disease (GERD). During a session on extraesophageal symptoms, Dr. Roman relayed two key messages: In patients with a chronic cough, reflux absolutely must be documented, and proton pump inhibitors (PPIs) must only be prescribed when a diagnosis of GERD has been made.
 

Overestimated Cause

Chronic cough is a widespread problem with a prevalence of between 9% and 33%, according to clinical studies. The root causes of this cough are varied; they’re mainly related to the respiratory system (eg, asthma, chronic obstructive pulmonary disease, respiratory infections, or smoking) and the ear, nose, and throat field (eg, postnasal drip). What’s more, taking certain medicines, notably angiotensin-converting enzyme inhibitors, can also be at the root of this condition.

GERD is also a possible cause of a chronic cough but one that is likely overestimated. A 2023 Spanish study provides evidence of this; GERD was suspected to be linked to cough in 46% of patients (compared with 32% for asthma and 15% for postnasal drip).

The treatments most commonly prescribed include PPIs (79.6%) and respiratory medicines (87.8%). Note that antibiotics are administered empirically to 28.6% of patients. For Roman, “the blame for a chronic cough is too often assigned to GERD, especially considering that in this study, only 43% of patients had seen a gastroenterologist, 27% had an endoscopy, and 24% had undergone esophageal pH monitoring.”

Added to this observation is the difficulty of establishing a causal link between a cough and GERD when the latter is present, even when the patient has had a diagnosis of GERD. Of course, a link between the two does not necessarily imply a cause–effect relationship, especially given that studies have shown that a cough itself can induce GERD. Studies using automatic cough detection to count cough events have shown that GERD certainly preceded a cough in 48% of patients, but in 56% of cases, it was the cough that came before the GERD. What’s more, both mechanisms were present in one third of patients.
 

Prescribing PPIs Effectively

PPIs are commonly prescribed as a test treatment. However, their efficacy is in no way proof of the existence of underlying GERD. In reality, all placebo-controlled studies have shown that in cases where no prior diagnosis of GERD has been made, PPIs have no superior efficacy.

If reflux has been proven, then the improvement provided by PPIs, compared with placebo, is between 12% and 35%. Therefore, it is essential that the presence of GERD be demonstrated, particularly if the patient has no characteristic symptoms of GERD, such as heartburn and acid reflux.

Response factors to PPIs were evaluated in 178 Italian patients with a chronic cough who presented with suspected GERD. Of those, 45% responded to treatment. It has been shown that typical symptoms, severe esophagitis (grade C/D), abnormal acid exposure, and low levels of nocturnal baseline impedance were independent factors of response to treatment.

In conclusion, patients with a chronic cough must be comprehensively tested for GERD before a long-term prescription of PPIs can be considered.
 

Cough Reflex Threshold

Various studies have also revealed that patients with GERD and presenting with a chronic cough have an increased sensitivity to the cough reflex. This hypersensitivity to the cough reflex has inspired several trials involving gabapentin and baclofen. A randomized controlled trial found the two treatments to be equally effective, achieving improvement of around 50%.

Lesogaberan, a new GABA(B) receptor agonist acting on the peripheral nervous system which is better tolerated than baclofen, a drug belonging to the same therapeutic class, showed a 26% benefit over placebo, but it was not statistically significant; lesogaberan has not been developed further.

Anti-reflux surgery is an option. A 2021 meta-analysis revealed that 84% of patients enrolled in these studies saw an improvement in their symptoms. However, these results must be regarded with caution because none of these studies were controlled, most of them were retrospective with very heterogeneous patient populations, and the data obtained on postoperative reflux control were often found to be lacking.

A retrospective study showed that among the factors for nonresponse or recurrence of symptoms after anti-reflux surgery, lack of response to medical treatment and extraesophageal symptoms such as a cough were significant factors. Consequently, potential candidates for surgery must be rigorously screened before being considered for such a procedure.

The recent recommendations for good practice published by the American Gastroenterological Association also insist that lack of response to medical treatment is a major factor for failure of surgical treatment.

In sum, patients with a chronic cough can be prescribed PPIs as first-line treatment if they have typical symptoms of GERD. In the event of treatment failure or isolated cough without typical symptoms, tests to confirm or rule out GERD are essential (such as endoscopy, esophageal pH monitoring, or impedance-pH monitoring).
 

This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.

TOPLINE:

Children with asthma exposed to worsening psychosocial environmental factors during childhood were more likely to have more severe asthma symptoms than those without such exposures.

METHODOLOGY:

• The researchers reviewed data from the Longitudinal Study of Australian Children, a nationally representative cohort that also collects data on the health, psychosocial, and environmental status of parents, and used three multivariate models to assess the impact of psychosocial environmental factors on asthma symptoms at ages 1 year, 4-5 years, and 14-15 years.
• The study population included 3,917 children aged 0-15 years who were sorted into three asthma symptom trajectory groups (low/no asthma, transient high asthma, and persistent high asthma); asthma symptoms were defined as a history of chest wheezing lasting at least a week within the past 12 months.
• The researchers identified several psychosocial environmental factors as exposure variables on the basis of literature reviews; these factors were maternal depression, parents’ financial hardship, parental availability, and parental stressful life events.

TAKEAWAY:

• The mean scores of psychosocial factors for the overall study population remained stable over time, but groups of children exposed to bad trajectories of psychosocial factors were significantly more likely to have transient high and persistent high asthma symptoms.
• In the first year of life, only parents’ stressful life events were significantly associated with the persistent high asthma symptom trajectory group in an adjusted analysis.
• At age 4-5 years, maternal depression, low parental availability, and parents’ stressful life events were significantly associated with persistent high asthma; parents’ financial hardship was significantly associated with transient high asthma symptoms.
• At age 14-15 years, children exposed to “moderate and increasing” maternal depression, “moderate and declining” parents’ financial hardship, and “moderate and increasing” parents’ stressful life events were significantly associated with persistent high asthma versus no or low asthma, with relative risk ratios of 1.55, 1.40, and 1.77, respectively.

IN PRACTICE:

The study findings highlight the need for policy makers to take action to improve asthma control in children by reducing exposure to harmful psychosocial environmental factors, the researchers concluded.

SOURCE:

The lead author of the study was K.M. Shahunja, MBBS, PhD candidate at the University of Queensland, Brisbane, Australia. The study was published online in Pediatric Pulmonology.

LIMITATIONS:

The study is the first known to examine asthma symptom trajectories at different developmental stages, but participant attrition and missing values were limiting factors, as was the inability to account for all potential psychosocial environmental factors that might influence asthma symptoms in childhood.

DISCLOSURES:

The study received no outside funding. The researchers had no financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

TOPLINE:

Children with asthma exposed to worsening psychosocial environmental factors during childhood were more likely to have more severe asthma symptoms than those without such exposures.

METHODOLOGY:

• The researchers reviewed data from the Longitudinal Study of Australian Children, a nationally representative cohort that also collects data on the health, psychosocial, and environmental status of parents, and used three multivariate models to assess the impact of psychosocial environmental factors on asthma symptoms at ages 1 year, 4-5 years, and 14-15 years.
• The study population included 3,917 children aged 0-15 years who were sorted into three asthma symptom trajectory groups (low/no asthma, transient high asthma, and persistent high asthma); asthma symptoms were defined as a history of chest wheezing lasting at least a week within the past 12 months.
• The researchers identified several psychosocial environmental factors as exposure variables on the basis of literature reviews; these factors were maternal depression, parents’ financial hardship, parental availability, and parental stressful life events.

TAKEAWAY:

• The mean scores of psychosocial factors for the overall study population remained stable over time, but groups of children exposed to bad trajectories of psychosocial factors were significantly more likely to have transient high and persistent high asthma symptoms.
• In the first year of life, only parents’ stressful life events were significantly associated with the persistent high asthma symptom trajectory group in an adjusted analysis.
• At age 4-5 years, maternal depression, low parental availability, and parents’ stressful life events were significantly associated with persistent high asthma; parents’ financial hardship was significantly associated with transient high asthma symptoms.
• At age 14-15 years, children exposed to “moderate and increasing” maternal depression, “moderate and declining” parents’ financial hardship, and “moderate and increasing” parents’ stressful life events were significantly associated with persistent high asthma versus no or low asthma, with relative risk ratios of 1.55, 1.40, and 1.77, respectively.

IN PRACTICE:

The study findings highlight the need for policy makers to take action to improve asthma control in children by reducing exposure to harmful psychosocial environmental factors, the researchers concluded.

SOURCE:

The lead author of the study was K.M. Shahunja, MBBS, PhD candidate at the University of Queensland, Brisbane, Australia. The study was published online in Pediatric Pulmonology.

LIMITATIONS:

The study is the first known to examine asthma symptom trajectories at different developmental stages, but participant attrition and missing values were limiting factors, as was the inability to account for all potential psychosocial environmental factors that might influence asthma symptoms in childhood.

DISCLOSURES:

The study received no outside funding. The researchers had no financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

TOPLINE:

Children with asthma exposed to worsening psychosocial environmental factors during childhood were more likely to have more severe asthma symptoms than those without such exposures.

METHODOLOGY:

• The researchers reviewed data from the Longitudinal Study of Australian Children, a nationally representative cohort that also collects data on the health, psychosocial, and environmental status of parents, and used three multivariate models to assess the impact of psychosocial environmental factors on asthma symptoms at ages 1 year, 4-5 years, and 14-15 years.
• The study population included 3,917 children aged 0-15 years who were sorted into three asthma symptom trajectory groups (low/no asthma, transient high asthma, and persistent high asthma); asthma symptoms were defined as a history of chest wheezing lasting at least a week within the past 12 months.
• The researchers identified several psychosocial environmental factors as exposure variables on the basis of literature reviews; these factors were maternal depression, parents’ financial hardship, parental availability, and parental stressful life events.

TAKEAWAY:

• The mean scores of psychosocial factors for the overall study population remained stable over time, but groups of children exposed to bad trajectories of psychosocial factors were significantly more likely to have transient high and persistent high asthma symptoms.
• In the first year of life, only parents’ stressful life events were significantly associated with the persistent high asthma symptom trajectory group in an adjusted analysis.
• At age 4-5 years, maternal depression, low parental availability, and parents’ stressful life events were significantly associated with persistent high asthma; parents’ financial hardship was significantly associated with transient high asthma symptoms.
• At age 14-15 years, children exposed to “moderate and increasing” maternal depression, “moderate and declining” parents’ financial hardship, and “moderate and increasing” parents’ stressful life events were significantly associated with persistent high asthma versus no or low asthma, with relative risk ratios of 1.55, 1.40, and 1.77, respectively.

IN PRACTICE:

The study findings highlight the need for policy makers to take action to improve asthma control in children by reducing exposure to harmful psychosocial environmental factors, the researchers concluded.

SOURCE:

The lead author of the study was K.M. Shahunja, MBBS, PhD candidate at the University of Queensland, Brisbane, Australia. The study was published online in Pediatric Pulmonology.

LIMITATIONS:

The study is the first known to examine asthma symptom trajectories at different developmental stages, but participant attrition and missing values were limiting factors, as was the inability to account for all potential psychosocial environmental factors that might influence asthma symptoms in childhood.

DISCLOSURES:

The study received no outside funding. The researchers had no financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

ANAHEIM, CALIF. – Gargling and nasal rinsing with saltwater several times a day appeared to be associated with significantly lower COVID-19 hospitalization rates in a small, randomized, double-blind, controlled study.

“The hypothesis was that interventions that target the upper respiratory tract may reduce the frequency and duration of upper respiratory symptoms associated with COVID-19,” said Sebastian Espinoza, first author of the study; he is with Trinity University, San Antonio.

Adults aged 18-65 years who tested positive for SARS-CoV-2 on polymerase chain reaction (PCR) testing between 2020 and 2022 were randomly selected to use low- or high-dose saltwater regimens for 14 days at the Harris Health System, Houston. For patients to be included in the study, 14 days had to have elapsed since the onset of any symptoms associated with COVID.

The low dose was 2.13 grams of salt dissolved in 8 ounces of warm water, and the high dose was 6 grams. Participants gargled the saltwater and used it as a nasal rinse for 5 minutes four times a day.

Primary outcomes included frequency and duration of symptoms associated with SARS-CoV-2 infection; secondary outcomes included admission to the hospital or the intensive care unit, mechanical ventilatory support, or death.

The findings were presented in a poster at the annual meeting of the American College of Allergy, Asthma, and Immunology.

Fifty-eight people were randomly assigned to either the low-saline (n = 27) or the high-saline (n = 28) group; three patients were lost to follow-up in both these groups. The reference control population consisted of 9,398 people with confirmed SARS-CoV-2 infection. Rates of vaccination were similar for all participants.

Hospitalization rates in the low- (18.5%) and high- (21.4%) saline groups were significantly lower than in the reference control population (58.8%; P < .001). No significant differences were noted in other outcomes among these groups.

The average age of patients in the control population (n = 9,398) was 45 years. The average age was similar in the low- and high-saline groups. In the low-saline group (n = 27), the average age was 39, and in the high-saline group, the average age was 41.

In all three groups, body mass index was between 29.6 and 31.7.

Exclusion criteria included chronic hypertension or participation in another interventional study.
 

‘Low risk, small potential benefit’

Allergist Zach Rubin, MD, a spokesperson for the ACAAI, said in an interview that the findings are in line with other small studies that previously reported some benefit in using nasal saline irrigation and gargling to treat a SARS-CoV-2 infection.

“This is a type of intervention that is low risk with some small potential benefit,” he said.

The researchers did not evaluate the potential reason for the saline regimen’s association with fewer hospitalizations, but Dr. Rubin said, “It may be possible that nasal saline irrigation and gargling help improve viral clearance and reduce the risk of microaspiration into the lungs, so it may be possible that this intervention could reduce the risk of pneumonia, which is a major cause of hospitalization.”

Dr. Rubin, who is an allergist at Oak Brook Allergists, Ill., said, “I generally recommend nasal saline irrigation to my patients for allergic rhinitis and viral upper respiratory infections already. It can help reduce symptoms such as nasal congestion, rhinorrhea, postnasal drip, and sinus pain and pressure.”

The intervention may be reasonable beyond an adult population, he said.

“This could be used for pediatric patients as well, if they are developmentally ready to try this intervention,” he said.

Mr. Espinoza said further study is warranted, but he said that if confirmed in later trials, the simple intervention may be particularly helpful in low-resource settings.

Mr. Espinoza and Dr. Rubin have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

ANAHEIM, CALIF. – Gargling and nasal rinsing with saltwater several times a day appeared to be associated with significantly lower COVID-19 hospitalization rates in a small, randomized, double-blind, controlled study.

“The hypothesis was that interventions that target the upper respiratory tract may reduce the frequency and duration of upper respiratory symptoms associated with COVID-19,” said Sebastian Espinoza, first author of the study; he is with Trinity University, San Antonio.

Adults aged 18-65 years who tested positive for SARS-CoV-2 on polymerase chain reaction (PCR) testing between 2020 and 2022 were randomly selected to use low- or high-dose saltwater regimens for 14 days at the Harris Health System, Houston. For patients to be included in the study, 14 days had to have elapsed since the onset of any symptoms associated with COVID.

The low dose was 2.13 grams of salt dissolved in 8 ounces of warm water, and the high dose was 6 grams. Participants gargled the saltwater and used it as a nasal rinse for 5 minutes four times a day.

Primary outcomes included frequency and duration of symptoms associated with SARS-CoV-2 infection; secondary outcomes included admission to the hospital or the intensive care unit, mechanical ventilatory support, or death.

The findings were presented in a poster at the annual meeting of the American College of Allergy, Asthma, and Immunology.

Fifty-eight people were randomly assigned to either the low-saline (n = 27) or the high-saline (n = 28) group; three patients were lost to follow-up in both these groups. The reference control population consisted of 9,398 people with confirmed SARS-CoV-2 infection. Rates of vaccination were similar for all participants.

Hospitalization rates in the low- (18.5%) and high- (21.4%) saline groups were significantly lower than in the reference control population (58.8%; P < .001). No significant differences were noted in other outcomes among these groups.

The average age of patients in the control population (n = 9,398) was 45 years. The average age was similar in the low- and high-saline groups. In the low-saline group (n = 27), the average age was 39, and in the high-saline group, the average age was 41.

In all three groups, body mass index was between 29.6 and 31.7.

Exclusion criteria included chronic hypertension or participation in another interventional study.
 

‘Low risk, small potential benefit’

Allergist Zach Rubin, MD, a spokesperson for the ACAAI, said in an interview that the findings are in line with other small studies that previously reported some benefit in using nasal saline irrigation and gargling to treat a SARS-CoV-2 infection.

“This is a type of intervention that is low risk with some small potential benefit,” he said.

The researchers did not evaluate the potential reason for the saline regimen’s association with fewer hospitalizations, but Dr. Rubin said, “It may be possible that nasal saline irrigation and gargling help improve viral clearance and reduce the risk of microaspiration into the lungs, so it may be possible that this intervention could reduce the risk of pneumonia, which is a major cause of hospitalization.”

Dr. Rubin, who is an allergist at Oak Brook Allergists, Ill., said, “I generally recommend nasal saline irrigation to my patients for allergic rhinitis and viral upper respiratory infections already. It can help reduce symptoms such as nasal congestion, rhinorrhea, postnasal drip, and sinus pain and pressure.”

The intervention may be reasonable beyond an adult population, he said.

“This could be used for pediatric patients as well, if they are developmentally ready to try this intervention,” he said.

Mr. Espinoza said further study is warranted, but he said that if confirmed in later trials, the simple intervention may be particularly helpful in low-resource settings.

Mr. Espinoza and Dr. Rubin have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

ANAHEIM, CALIF. – Gargling and nasal rinsing with saltwater several times a day appeared to be associated with significantly lower COVID-19 hospitalization rates in a small, randomized, double-blind, controlled study.

“The hypothesis was that interventions that target the upper respiratory tract may reduce the frequency and duration of upper respiratory symptoms associated with COVID-19,” said Sebastian Espinoza, first author of the study; he is with Trinity University, San Antonio.

Adults aged 18-65 years who tested positive for SARS-CoV-2 on polymerase chain reaction (PCR) testing between 2020 and 2022 were randomly selected to use low- or high-dose saltwater regimens for 14 days at the Harris Health System, Houston. For patients to be included in the study, 14 days had to have elapsed since the onset of any symptoms associated with COVID.

The low dose was 2.13 grams of salt dissolved in 8 ounces of warm water, and the high dose was 6 grams. Participants gargled the saltwater and used it as a nasal rinse for 5 minutes four times a day.

Primary outcomes included frequency and duration of symptoms associated with SARS-CoV-2 infection; secondary outcomes included admission to the hospital or the intensive care unit, mechanical ventilatory support, or death.

The findings were presented in a poster at the annual meeting of the American College of Allergy, Asthma, and Immunology.

Fifty-eight people were randomly assigned to either the low-saline (n = 27) or the high-saline (n = 28) group; three patients were lost to follow-up in both these groups. The reference control population consisted of 9,398 people with confirmed SARS-CoV-2 infection. Rates of vaccination were similar for all participants.

Hospitalization rates in the low- (18.5%) and high- (21.4%) saline groups were significantly lower than in the reference control population (58.8%; P < .001). No significant differences were noted in other outcomes among these groups.

The average age of patients in the control population (n = 9,398) was 45 years. The average age was similar in the low- and high-saline groups. In the low-saline group (n = 27), the average age was 39, and in the high-saline group, the average age was 41.

In all three groups, body mass index was between 29.6 and 31.7.

Exclusion criteria included chronic hypertension or participation in another interventional study.
 

‘Low risk, small potential benefit’

Allergist Zach Rubin, MD, a spokesperson for the ACAAI, said in an interview that the findings are in line with other small studies that previously reported some benefit in using nasal saline irrigation and gargling to treat a SARS-CoV-2 infection.

“This is a type of intervention that is low risk with some small potential benefit,” he said.

The researchers did not evaluate the potential reason for the saline regimen’s association with fewer hospitalizations, but Dr. Rubin said, “It may be possible that nasal saline irrigation and gargling help improve viral clearance and reduce the risk of microaspiration into the lungs, so it may be possible that this intervention could reduce the risk of pneumonia, which is a major cause of hospitalization.”

Dr. Rubin, who is an allergist at Oak Brook Allergists, Ill., said, “I generally recommend nasal saline irrigation to my patients for allergic rhinitis and viral upper respiratory infections already. It can help reduce symptoms such as nasal congestion, rhinorrhea, postnasal drip, and sinus pain and pressure.”

The intervention may be reasonable beyond an adult population, he said.

“This could be used for pediatric patients as well, if they are developmentally ready to try this intervention,” he said.

Mr. Espinoza said further study is warranted, but he said that if confirmed in later trials, the simple intervention may be particularly helpful in low-resource settings.

Mr. Espinoza and Dr. Rubin have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

ANAHEIM, CALIF. – Patients with uncontrolled asthma are seen more often by primary care providers (PCPs) than by allergists, but a survey has found that 42% of PCPs are unfamiliar with the biologics that have markedly improved asthma treatment options over the past 2 decades.

Bijalben Patel, MD, with the department of internal medicine, University of South Florida, Tampa, said in an interview that in addition to the considerable lack of knowledge of biologics in primary care, she was surprised that 77% of survey participants stated they only referred patients to specialists after two or more exacerbations.

“This is important because these patients are considered to have exacerbation-prone asthma, which should be managed by specialists,” she said.

She said that being “unfamiliar” with biologics meant that the healthcare provider may have heard of biologics but did not know the various types, initiation criteria, or side effects.

The researchers administered a REDCap (Research Electronic Data Capture) survey by email to primary care attending and resident physicians in the departments of internal medicine, family medicine, and pediatrics, and 85 responded. Responses were compared using Chi-square tests.

Patel presented the results of the survey at the annual meeting of the American College of Allergy, Asthma & Immunology.

82% do not order labs

Familiarity did not vary in primary care with number of patients with asthma seen per month, the researchers noted.

“Also, the frequency of PCP referrals to a specialist did not change familiarity with biologics (P = .260) or eligibility criteria (P = .393),” the researchers said.

In addition, they found that 82% of those surveyed do not order labs, and 90% do not use absolute eosinophil count to guide care.

Dr. Patel explained that lab work such as obtaining IgE levels and a complete blood count with a differential and examining the absolute eosinophil count help identify patients who are at high risk for future exacerbation and also treatable phenotypic traits, which can be targeted with biologic therapy. 

Angela Duff Hogan, MD, vice chair of the ACAAI Asthma Committee and professor of pediatrics at Eastern Virginia Medical School, Norfolk, said in an interview that she finds the delay on referrals the most concerning finding in the survey results.

“I’m not as concerned they are not obtaining labs,” said Dr. Hogan, who was not part of the study. “The specialist can do that. It’s more concerning they wait so long to refer a patient with poorly controlled asthma. We know that asthma patients treated by an allergist have better asthma control, better quality of life, and reduced health care costs.”
 

Asthma specialists ‘need better marketing’

Dr. Hogan said that the results show the need for more studies to demonstrate that asthma specialists can improve outcomes and reduce healthcare costs.

“Objective data is more convincing than subjective data,” she noted. “As a specialty, we need to disseminate more information about asthma management, the “new” asthma guidelines, SMART/MART therapy, and the importance of biologicals in asthma. We need better marketing as a specialty in asthma care.”

Dr. Patel said that their goal with the study is to raise awareness about the available asthma biologic therapies, which have been improving care for 2 decades.

“The results of the survey point to the need to improve the communication between primary care physicians and asthma care specialists, including regarding use of biologics,” senior author Juan Carlos Cardet, MD, MPH, also an allergy specialist at USF, added in a press release. “Biologics have become an important tool in the treatment of asthma and other allergic diseases such as atopic dermatitis (eczema), chronic rhinosinusitis with nasal polyps and eosinophilic esophagitis, and can prevent substantial ill results from occurring in patients who are eligible for them.”

The study authors and Dr. Hogan disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

ANAHEIM, CALIF. – Patients with uncontrolled asthma are seen more often by primary care providers (PCPs) than by allergists, but a survey has found that 42% of PCPs are unfamiliar with the biologics that have markedly improved asthma treatment options over the past 2 decades.

Bijalben Patel, MD, with the department of internal medicine, University of South Florida, Tampa, said in an interview that in addition to the considerable lack of knowledge of biologics in primary care, she was surprised that 77% of survey participants stated they only referred patients to specialists after two or more exacerbations.

“This is important because these patients are considered to have exacerbation-prone asthma, which should be managed by specialists,” she said.

She said that being “unfamiliar” with biologics meant that the healthcare provider may have heard of biologics but did not know the various types, initiation criteria, or side effects.

The researchers administered a REDCap (Research Electronic Data Capture) survey by email to primary care attending and resident physicians in the departments of internal medicine, family medicine, and pediatrics, and 85 responded. Responses were compared using Chi-square tests.

Patel presented the results of the survey at the annual meeting of the American College of Allergy, Asthma & Immunology.

82% do not order labs

Familiarity did not vary in primary care with number of patients with asthma seen per month, the researchers noted.

“Also, the frequency of PCP referrals to a specialist did not change familiarity with biologics (P = .260) or eligibility criteria (P = .393),” the researchers said.

In addition, they found that 82% of those surveyed do not order labs, and 90% do not use absolute eosinophil count to guide care.

Dr. Patel explained that lab work such as obtaining IgE levels and a complete blood count with a differential and examining the absolute eosinophil count help identify patients who are at high risk for future exacerbation and also treatable phenotypic traits, which can be targeted with biologic therapy. 

Angela Duff Hogan, MD, vice chair of the ACAAI Asthma Committee and professor of pediatrics at Eastern Virginia Medical School, Norfolk, said in an interview that she finds the delay on referrals the most concerning finding in the survey results.

“I’m not as concerned they are not obtaining labs,” said Dr. Hogan, who was not part of the study. “The specialist can do that. It’s more concerning they wait so long to refer a patient with poorly controlled asthma. We know that asthma patients treated by an allergist have better asthma control, better quality of life, and reduced health care costs.”
 

Asthma specialists ‘need better marketing’

Dr. Hogan said that the results show the need for more studies to demonstrate that asthma specialists can improve outcomes and reduce healthcare costs.

“Objective data is more convincing than subjective data,” she noted. “As a specialty, we need to disseminate more information about asthma management, the “new” asthma guidelines, SMART/MART therapy, and the importance of biologicals in asthma. We need better marketing as a specialty in asthma care.”

Dr. Patel said that their goal with the study is to raise awareness about the available asthma biologic therapies, which have been improving care for 2 decades.

“The results of the survey point to the need to improve the communication between primary care physicians and asthma care specialists, including regarding use of biologics,” senior author Juan Carlos Cardet, MD, MPH, also an allergy specialist at USF, added in a press release. “Biologics have become an important tool in the treatment of asthma and other allergic diseases such as atopic dermatitis (eczema), chronic rhinosinusitis with nasal polyps and eosinophilic esophagitis, and can prevent substantial ill results from occurring in patients who are eligible for them.”

The study authors and Dr. Hogan disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

ANAHEIM, CALIF. – Patients with uncontrolled asthma are seen more often by primary care providers (PCPs) than by allergists, but a survey has found that 42% of PCPs are unfamiliar with the biologics that have markedly improved asthma treatment options over the past 2 decades.

Bijalben Patel, MD, with the department of internal medicine, University of South Florida, Tampa, said in an interview that in addition to the considerable lack of knowledge of biologics in primary care, she was surprised that 77% of survey participants stated they only referred patients to specialists after two or more exacerbations.

“This is important because these patients are considered to have exacerbation-prone asthma, which should be managed by specialists,” she said.

She said that being “unfamiliar” with biologics meant that the healthcare provider may have heard of biologics but did not know the various types, initiation criteria, or side effects.

The researchers administered a REDCap (Research Electronic Data Capture) survey by email to primary care attending and resident physicians in the departments of internal medicine, family medicine, and pediatrics, and 85 responded. Responses were compared using Chi-square tests.

Patel presented the results of the survey at the annual meeting of the American College of Allergy, Asthma & Immunology.

82% do not order labs

Familiarity did not vary in primary care with number of patients with asthma seen per month, the researchers noted.

“Also, the frequency of PCP referrals to a specialist did not change familiarity with biologics (P = .260) or eligibility criteria (P = .393),” the researchers said.

In addition, they found that 82% of those surveyed do not order labs, and 90% do not use absolute eosinophil count to guide care.

Dr. Patel explained that lab work such as obtaining IgE levels and a complete blood count with a differential and examining the absolute eosinophil count help identify patients who are at high risk for future exacerbation and also treatable phenotypic traits, which can be targeted with biologic therapy. 

Angela Duff Hogan, MD, vice chair of the ACAAI Asthma Committee and professor of pediatrics at Eastern Virginia Medical School, Norfolk, said in an interview that she finds the delay on referrals the most concerning finding in the survey results.

“I’m not as concerned they are not obtaining labs,” said Dr. Hogan, who was not part of the study. “The specialist can do that. It’s more concerning they wait so long to refer a patient with poorly controlled asthma. We know that asthma patients treated by an allergist have better asthma control, better quality of life, and reduced health care costs.”
 

Asthma specialists ‘need better marketing’

Dr. Hogan said that the results show the need for more studies to demonstrate that asthma specialists can improve outcomes and reduce healthcare costs.

“Objective data is more convincing than subjective data,” she noted. “As a specialty, we need to disseminate more information about asthma management, the “new” asthma guidelines, SMART/MART therapy, and the importance of biologicals in asthma. We need better marketing as a specialty in asthma care.”

Dr. Patel said that their goal with the study is to raise awareness about the available asthma biologic therapies, which have been improving care for 2 decades.

“The results of the survey point to the need to improve the communication between primary care physicians and asthma care specialists, including regarding use of biologics,” senior author Juan Carlos Cardet, MD, MPH, also an allergy specialist at USF, added in a press release. “Biologics have become an important tool in the treatment of asthma and other allergic diseases such as atopic dermatitis (eczema), chronic rhinosinusitis with nasal polyps and eosinophilic esophagitis, and can prevent substantial ill results from occurring in patients who are eligible for them.”

The study authors and Dr. Hogan disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Phytoestrogens show potential as a treatment for menopausal women with late-onset asthma that may relieve symptoms of both conditions, according to a new review.

Fluctuations in female sex steroid hormones during menstrual periods have been linked to asthma exacerbations, and the absence of these hormones during childhood and menopause has been associated with fewer and less severe asthma episodes, wrote Bettina Sommer, PhD, of the Instituto Nacional de Enfermedades Respiratorias, Mexico City, and colleagues.

Late-onset asthma (LOA) has been categorized as a specific asthmatic phenotype that includes menopausal women, and research is needed to explore therapeutic alternatives that might provide relief to older women suffering from LOA, they said.

In a review published in the International Journal of Molecular Sciences, the researchers outlined the potential of phytoestrogens to manage LOA as well as symptoms of menopause.

LOA is often nonatopic and distinguished by a lack of eosinophilic inflammation; it is also associated with obesity and pollutants such as cigarette smoke. LOA is more common in women versus men, and develops between ages 27 and 65 years, the researchers wrote. Very late-onset asthma, which develops in women aged 65 years and older, is related to low levels of total lack of circulating estrogens.

Previous studies have shown that hormone therapy reduces the risk of LOA in menopausal women, but concerns about side effects persist. Phytochemicals offer a low-risk alternative, but phytoestrogen-based hormone therapy and its role in LOA have not been well studied, the researchers wrote.

Estrogen receptors (ERs) have two intracellular isoforms, alpha and beta. “Notably, the literature sustains that ERs expression differs between asthmatics and nonasthmatics,” and mainly the beta ERs are up-regulated in asthma or during inflammations, the researchers said. Phytoestrogens activate ER and benefit postmenopausal women, especially those with asthma, in addition to their anti-inflammatory and antioxidant properties.

Studies using mouse models have shown that E2 phytoestrogen supplementation in mice both increases the expression of antioxidant enzymes and reduces inflammation, according to the researchers. Age-related changes in hormonal statues, immunology, and systemic inflammation may predispose older adults to more infections and asthma exacerbations, but also might drive the development of LOA.

As another example of potential connections between phytoestrogen and asthma, phytoestrogen’s action on an estrogen receptor, notably the beta-ER, was associated with lowered airway hyperresponsiveness in a mouse model, and beta-ER knockout mice showed reduced lung function, compared with wild-type and alpha-ER knockout mice.

More research is needed, but novel therapies using phytoestrogens offer an added advantage to older women with LOA by potentially easing some menopause symptoms with fewer side effects than other options, the researchers wrote. “They may also contribute to more efficient responses to infection and inflammation leading menopausal women to a much better quality of life.”

The study was funded by the Instituto Nacional de Enfermedades Respiratorias, Consejo Nacional de Ciencia y Tecnología, Programa de Apoyo a Proyectos de Investigación e Innovación Tecnológica, and the Universidad Nacional Autonoma de Mexico. The researchers had no financial conflicts to disclose.


 

Phytoestrogens show potential as a treatment for menopausal women with late-onset asthma that may relieve symptoms of both conditions, according to a new review.

Fluctuations in female sex steroid hormones during menstrual periods have been linked to asthma exacerbations, and the absence of these hormones during childhood and menopause has been associated with fewer and less severe asthma episodes, wrote Bettina Sommer, PhD, of the Instituto Nacional de Enfermedades Respiratorias, Mexico City, and colleagues.

Late-onset asthma (LOA) has been categorized as a specific asthmatic phenotype that includes menopausal women, and research is needed to explore therapeutic alternatives that might provide relief to older women suffering from LOA, they said.

In a review published in the International Journal of Molecular Sciences, the researchers outlined the potential of phytoestrogens to manage LOA as well as symptoms of menopause.

LOA is often nonatopic and distinguished by a lack of eosinophilic inflammation; it is also associated with obesity and pollutants such as cigarette smoke. LOA is more common in women versus men, and develops between ages 27 and 65 years, the researchers wrote. Very late-onset asthma, which develops in women aged 65 years and older, is related to low levels of total lack of circulating estrogens.

Previous studies have shown that hormone therapy reduces the risk of LOA in menopausal women, but concerns about side effects persist. Phytochemicals offer a low-risk alternative, but phytoestrogen-based hormone therapy and its role in LOA have not been well studied, the researchers wrote.

Estrogen receptors (ERs) have two intracellular isoforms, alpha and beta. “Notably, the literature sustains that ERs expression differs between asthmatics and nonasthmatics,” and mainly the beta ERs are up-regulated in asthma or during inflammations, the researchers said. Phytoestrogens activate ER and benefit postmenopausal women, especially those with asthma, in addition to their anti-inflammatory and antioxidant properties.

Studies using mouse models have shown that E2 phytoestrogen supplementation in mice both increases the expression of antioxidant enzymes and reduces inflammation, according to the researchers. Age-related changes in hormonal statues, immunology, and systemic inflammation may predispose older adults to more infections and asthma exacerbations, but also might drive the development of LOA.

As another example of potential connections between phytoestrogen and asthma, phytoestrogen’s action on an estrogen receptor, notably the beta-ER, was associated with lowered airway hyperresponsiveness in a mouse model, and beta-ER knockout mice showed reduced lung function, compared with wild-type and alpha-ER knockout mice.

More research is needed, but novel therapies using phytoestrogens offer an added advantage to older women with LOA by potentially easing some menopause symptoms with fewer side effects than other options, the researchers wrote. “They may also contribute to more efficient responses to infection and inflammation leading menopausal women to a much better quality of life.”

The study was funded by the Instituto Nacional de Enfermedades Respiratorias, Consejo Nacional de Ciencia y Tecnología, Programa de Apoyo a Proyectos de Investigación e Innovación Tecnológica, and the Universidad Nacional Autonoma de Mexico. The researchers had no financial conflicts to disclose.


 

Phytoestrogens show potential as a treatment for menopausal women with late-onset asthma that may relieve symptoms of both conditions, according to a new review.

Fluctuations in female sex steroid hormones during menstrual periods have been linked to asthma exacerbations, and the absence of these hormones during childhood and menopause has been associated with fewer and less severe asthma episodes, wrote Bettina Sommer, PhD, of the Instituto Nacional de Enfermedades Respiratorias, Mexico City, and colleagues.

Late-onset asthma (LOA) has been categorized as a specific asthmatic phenotype that includes menopausal women, and research is needed to explore therapeutic alternatives that might provide relief to older women suffering from LOA, they said.

In a review published in the International Journal of Molecular Sciences, the researchers outlined the potential of phytoestrogens to manage LOA as well as symptoms of menopause.

LOA is often nonatopic and distinguished by a lack of eosinophilic inflammation; it is also associated with obesity and pollutants such as cigarette smoke. LOA is more common in women versus men, and develops between ages 27 and 65 years, the researchers wrote. Very late-onset asthma, which develops in women aged 65 years and older, is related to low levels of total lack of circulating estrogens.

Previous studies have shown that hormone therapy reduces the risk of LOA in menopausal women, but concerns about side effects persist. Phytochemicals offer a low-risk alternative, but phytoestrogen-based hormone therapy and its role in LOA have not been well studied, the researchers wrote.

Estrogen receptors (ERs) have two intracellular isoforms, alpha and beta. “Notably, the literature sustains that ERs expression differs between asthmatics and nonasthmatics,” and mainly the beta ERs are up-regulated in asthma or during inflammations, the researchers said. Phytoestrogens activate ER and benefit postmenopausal women, especially those with asthma, in addition to their anti-inflammatory and antioxidant properties.

Studies using mouse models have shown that E2 phytoestrogen supplementation in mice both increases the expression of antioxidant enzymes and reduces inflammation, according to the researchers. Age-related changes in hormonal statues, immunology, and systemic inflammation may predispose older adults to more infections and asthma exacerbations, but also might drive the development of LOA.

As another example of potential connections between phytoestrogen and asthma, phytoestrogen’s action on an estrogen receptor, notably the beta-ER, was associated with lowered airway hyperresponsiveness in a mouse model, and beta-ER knockout mice showed reduced lung function, compared with wild-type and alpha-ER knockout mice.

More research is needed, but novel therapies using phytoestrogens offer an added advantage to older women with LOA by potentially easing some menopause symptoms with fewer side effects than other options, the researchers wrote. “They may also contribute to more efficient responses to infection and inflammation leading menopausal women to a much better quality of life.”

The study was funded by the Instituto Nacional de Enfermedades Respiratorias, Consejo Nacional de Ciencia y Tecnología, Programa de Apoyo a Proyectos de Investigación e Innovación Tecnológica, and the Universidad Nacional Autonoma de Mexico. The researchers had no financial conflicts to disclose.


 

Among patients with asthma and comorbid gastroesophageal reflux disease (GERD), the biologic tezepelumab (Tezspire, Amgen) had similar efficacy at reducing exacerbations, improving lung function, and symptom control as observed in patients with asthma alone, according to a new post-hoc analysis of the phase 2b PATHWAY and phase 3 NAVIGATOR clinical trials.

GERD occurs in about 60% of asthma patients, and the comorbidity is associated with a greater risk of asthma exacerbations. “As we start doing subgroup analyses, we are looking at different comorbidities and reflux is one that’s very common and very impactful on asthma outcomes in a negative way, so it became an area of interest,” said Njira Lugogo, MD, who presented the study during a poster session at the annual meeting of the American College of Chest Physicians (CHEST). She is a professor of internal medicine and pulmonary critical care at the University of Michigan, Ann Arbor.

The analysis confirmed other findings, with comorbid GERD associated with more exacerbations, use of maintenance steroids, and high-dose inhaled steroids. “They had more disease activity, and the effect [of tezepelumab treatment] was similar whether you had reflux or didn’t have reflux. It did seem like the people without reflux had a slightly higher reduction in exacerbations, so maybe there is a slight difference, but overall it looked like both groups were really improving,” said Dr. Lugogo.

Tezepelumab is a newer biologic, having received Food and Drug Administration approval in 2021. It targets the epithelial cytokine thymic stromal lymphopoietin (TSLP), which contributes allergic inflammatory responses by acting on various innate immune cells, including dendritic cells, mast cells, and CD34+ progenitor cells. It is upregulated in the airways of asthma patients, with higher levels linked to more severe disease. A single-nucleotide polymorphism in the gene that codes TSLP has also been found to be protective against asthma, atopic asthma, and airway hyper-responsiveness.

Dr. Lugogo noted that TSLP could be a factor in how GERD may worsen trigger or worsen asthma. It is produced in the epithelium of the upper airway in response to injury, which could include aspiration into bronchial tubes attributable to GERD, and this could lead to a downstream inflammatory and immune response. “Reducing the production of or at least blocking TSLP from an epithelium that’s being irritated by acid reflux could have potential benefits. On the reverse side, could the continued presence of reflux blunt the expected response [to tezepelumab]? If someone has very severe reflux, maybe you’ve treated their asthma with tezepelumab, and they’re still having symptoms. Could it be a masquerading issue [where] you have untreated reflux contributing to ongoing symptoms, which you’re attributing to not being related to asthma? So it’s looking at it in two different ways,” said Dr. Lugogo.

TSLP is the only biologic available to treat patients with non–type 2 inflammation, which includes about 10% of adult patients, according to Dr. Lugogo. Its mechanism also influences eosinophilic and allergic asthma. When tezepelumab first became available, Dr. Lugogo noticed that physicians tended to switch to it from another biologic rather than starting it up front, but that may be changing. “I feel like more and more people are starting it up front as a therapeutic intervention, so there seems to be more and more people embracing its use in the treatment of severe asthma,” she said.

The analysis included 294 patients with asthma and GERD and 1,040 with asthma alone. Patients in the GERD comorbidity group were older (55.0 versus 48.6 years), had a higher mean body mass index (30.8 versus 27.8), and were more likely to be female (67.3% versus 63.0%).

Maintenance oral corticosteroid use was higher in the GERD group (17.0% versus 6.9%), as was use of high inhaled corticosteroid dose (78.2% versus 67.0%), frequency of nasal polyps in the previous 2 years (21.4% versus 13.8%), and experience of more than two exacerbations in the previous year (42.2% versus 34.6%).

There was a 65% reduction (95% confidence interval, 50%-76%) in annualized asthma exacerbation rate versus placebo with tezepelumab treatment in the GERD group, compared with a 58% reduction in the asthma-only group (95% CI, 48%-66%). The drug led to a 0.10 increase in forced expiratory volume in 1 second versus placebo (95% CI, 0.00-0.19) at week 52 in the GERD group, versus 0.15 (95% CI, 0.10-0.20) in the asthma-only group. Tezepelumab also improved week 52 ACQ-6 scores in the GERD group (–0.39 versus placebo; 95% CI, –0.63 to –0.14) and the asthma-only group (–0.32 versus placebo; 95% CI, –0.45 to –0.19).

The study adds to the evidence supporting tezepelumab as a promising new therapy, according to Muhammad Adrish, MD, who attended the poster session and was asked to comment on the study. “I think that this is a very interesting analysis in the sense that gastric reflux disease is a frequent comorbid condition that we see in patients with asthma, and a lot of these patients can have poor outcomes. When you look at the results from the data, you see that regardless of how sick they were and how much medication utilization these patients have at baseline, they still had a pretty decent response to tezepelumab. That speaks to the efficacy of that drug along a wide spectrum of patients,” said Dr. Adrish, who is an associate professor of pulmonary, critical care, and sleep medicine at Baylor College of Medicine, Houston.

The PATHWAY and NAVIGATOR studies were funded by Amgen. Dr. Lugogo has advised or consulted for AstraZeneca, Amgen, Regeneron, TEVA, Avillion, Sanofi, Novartis, Genentech, GSK, and Janssen. Dr. Adrish has no relevant financial disclosures.

Among patients with asthma and comorbid gastroesophageal reflux disease (GERD), the biologic tezepelumab (Tezspire, Amgen) had similar efficacy at reducing exacerbations, improving lung function, and symptom control as observed in patients with asthma alone, according to a new post-hoc analysis of the phase 2b PATHWAY and phase 3 NAVIGATOR clinical trials.

GERD occurs in about 60% of asthma patients, and the comorbidity is associated with a greater risk of asthma exacerbations. “As we start doing subgroup analyses, we are looking at different comorbidities and reflux is one that’s very common and very impactful on asthma outcomes in a negative way, so it became an area of interest,” said Njira Lugogo, MD, who presented the study during a poster session at the annual meeting of the American College of Chest Physicians (CHEST). She is a professor of internal medicine and pulmonary critical care at the University of Michigan, Ann Arbor.

The analysis confirmed other findings, with comorbid GERD associated with more exacerbations, use of maintenance steroids, and high-dose inhaled steroids. “They had more disease activity, and the effect [of tezepelumab treatment] was similar whether you had reflux or didn’t have reflux. It did seem like the people without reflux had a slightly higher reduction in exacerbations, so maybe there is a slight difference, but overall it looked like both groups were really improving,” said Dr. Lugogo.

Tezepelumab is a newer biologic, having received Food and Drug Administration approval in 2021. It targets the epithelial cytokine thymic stromal lymphopoietin (TSLP), which contributes allergic inflammatory responses by acting on various innate immune cells, including dendritic cells, mast cells, and CD34+ progenitor cells. It is upregulated in the airways of asthma patients, with higher levels linked to more severe disease. A single-nucleotide polymorphism in the gene that codes TSLP has also been found to be protective against asthma, atopic asthma, and airway hyper-responsiveness.

Dr. Lugogo noted that TSLP could be a factor in how GERD may worsen trigger or worsen asthma. It is produced in the epithelium of the upper airway in response to injury, which could include aspiration into bronchial tubes attributable to GERD, and this could lead to a downstream inflammatory and immune response. “Reducing the production of or at least blocking TSLP from an epithelium that’s being irritated by acid reflux could have potential benefits. On the reverse side, could the continued presence of reflux blunt the expected response [to tezepelumab]? If someone has very severe reflux, maybe you’ve treated their asthma with tezepelumab, and they’re still having symptoms. Could it be a masquerading issue [where] you have untreated reflux contributing to ongoing symptoms, which you’re attributing to not being related to asthma? So it’s looking at it in two different ways,” said Dr. Lugogo.

TSLP is the only biologic available to treat patients with non–type 2 inflammation, which includes about 10% of adult patients, according to Dr. Lugogo. Its mechanism also influences eosinophilic and allergic asthma. When tezepelumab first became available, Dr. Lugogo noticed that physicians tended to switch to it from another biologic rather than starting it up front, but that may be changing. “I feel like more and more people are starting it up front as a therapeutic intervention, so there seems to be more and more people embracing its use in the treatment of severe asthma,” she said.

The analysis included 294 patients with asthma and GERD and 1,040 with asthma alone. Patients in the GERD comorbidity group were older (55.0 versus 48.6 years), had a higher mean body mass index (30.8 versus 27.8), and were more likely to be female (67.3% versus 63.0%).

Maintenance oral corticosteroid use was higher in the GERD group (17.0% versus 6.9%), as was use of high inhaled corticosteroid dose (78.2% versus 67.0%), frequency of nasal polyps in the previous 2 years (21.4% versus 13.8%), and experience of more than two exacerbations in the previous year (42.2% versus 34.6%).

There was a 65% reduction (95% confidence interval, 50%-76%) in annualized asthma exacerbation rate versus placebo with tezepelumab treatment in the GERD group, compared with a 58% reduction in the asthma-only group (95% CI, 48%-66%). The drug led to a 0.10 increase in forced expiratory volume in 1 second versus placebo (95% CI, 0.00-0.19) at week 52 in the GERD group, versus 0.15 (95% CI, 0.10-0.20) in the asthma-only group. Tezepelumab also improved week 52 ACQ-6 scores in the GERD group (–0.39 versus placebo; 95% CI, –0.63 to –0.14) and the asthma-only group (–0.32 versus placebo; 95% CI, –0.45 to –0.19).

The study adds to the evidence supporting tezepelumab as a promising new therapy, according to Muhammad Adrish, MD, who attended the poster session and was asked to comment on the study. “I think that this is a very interesting analysis in the sense that gastric reflux disease is a frequent comorbid condition that we see in patients with asthma, and a lot of these patients can have poor outcomes. When you look at the results from the data, you see that regardless of how sick they were and how much medication utilization these patients have at baseline, they still had a pretty decent response to tezepelumab. That speaks to the efficacy of that drug along a wide spectrum of patients,” said Dr. Adrish, who is an associate professor of pulmonary, critical care, and sleep medicine at Baylor College of Medicine, Houston.

The PATHWAY and NAVIGATOR studies were funded by Amgen. Dr. Lugogo has advised or consulted for AstraZeneca, Amgen, Regeneron, TEVA, Avillion, Sanofi, Novartis, Genentech, GSK, and Janssen. Dr. Adrish has no relevant financial disclosures.

Among patients with asthma and comorbid gastroesophageal reflux disease (GERD), the biologic tezepelumab (Tezspire, Amgen) had similar efficacy at reducing exacerbations, improving lung function, and symptom control as observed in patients with asthma alone, according to a new post-hoc analysis of the phase 2b PATHWAY and phase 3 NAVIGATOR clinical trials.

GERD occurs in about 60% of asthma patients, and the comorbidity is associated with a greater risk of asthma exacerbations. “As we start doing subgroup analyses, we are looking at different comorbidities and reflux is one that’s very common and very impactful on asthma outcomes in a negative way, so it became an area of interest,” said Njira Lugogo, MD, who presented the study during a poster session at the annual meeting of the American College of Chest Physicians (CHEST). She is a professor of internal medicine and pulmonary critical care at the University of Michigan, Ann Arbor.

The analysis confirmed other findings, with comorbid GERD associated with more exacerbations, use of maintenance steroids, and high-dose inhaled steroids. “They had more disease activity, and the effect [of tezepelumab treatment] was similar whether you had reflux or didn’t have reflux. It did seem like the people without reflux had a slightly higher reduction in exacerbations, so maybe there is a slight difference, but overall it looked like both groups were really improving,” said Dr. Lugogo.

Tezepelumab is a newer biologic, having received Food and Drug Administration approval in 2021. It targets the epithelial cytokine thymic stromal lymphopoietin (TSLP), which contributes allergic inflammatory responses by acting on various innate immune cells, including dendritic cells, mast cells, and CD34+ progenitor cells. It is upregulated in the airways of asthma patients, with higher levels linked to more severe disease. A single-nucleotide polymorphism in the gene that codes TSLP has also been found to be protective against asthma, atopic asthma, and airway hyper-responsiveness.

Dr. Lugogo noted that TSLP could be a factor in how GERD may worsen trigger or worsen asthma. It is produced in the epithelium of the upper airway in response to injury, which could include aspiration into bronchial tubes attributable to GERD, and this could lead to a downstream inflammatory and immune response. “Reducing the production of or at least blocking TSLP from an epithelium that’s being irritated by acid reflux could have potential benefits. On the reverse side, could the continued presence of reflux blunt the expected response [to tezepelumab]? If someone has very severe reflux, maybe you’ve treated their asthma with tezepelumab, and they’re still having symptoms. Could it be a masquerading issue [where] you have untreated reflux contributing to ongoing symptoms, which you’re attributing to not being related to asthma? So it’s looking at it in two different ways,” said Dr. Lugogo.

TSLP is the only biologic available to treat patients with non–type 2 inflammation, which includes about 10% of adult patients, according to Dr. Lugogo. Its mechanism also influences eosinophilic and allergic asthma. When tezepelumab first became available, Dr. Lugogo noticed that physicians tended to switch to it from another biologic rather than starting it up front, but that may be changing. “I feel like more and more people are starting it up front as a therapeutic intervention, so there seems to be more and more people embracing its use in the treatment of severe asthma,” she said.

The analysis included 294 patients with asthma and GERD and 1,040 with asthma alone. Patients in the GERD comorbidity group were older (55.0 versus 48.6 years), had a higher mean body mass index (30.8 versus 27.8), and were more likely to be female (67.3% versus 63.0%).

Maintenance oral corticosteroid use was higher in the GERD group (17.0% versus 6.9%), as was use of high inhaled corticosteroid dose (78.2% versus 67.0%), frequency of nasal polyps in the previous 2 years (21.4% versus 13.8%), and experience of more than two exacerbations in the previous year (42.2% versus 34.6%).

There was a 65% reduction (95% confidence interval, 50%-76%) in annualized asthma exacerbation rate versus placebo with tezepelumab treatment in the GERD group, compared with a 58% reduction in the asthma-only group (95% CI, 48%-66%). The drug led to a 0.10 increase in forced expiratory volume in 1 second versus placebo (95% CI, 0.00-0.19) at week 52 in the GERD group, versus 0.15 (95% CI, 0.10-0.20) in the asthma-only group. Tezepelumab also improved week 52 ACQ-6 scores in the GERD group (–0.39 versus placebo; 95% CI, –0.63 to –0.14) and the asthma-only group (–0.32 versus placebo; 95% CI, –0.45 to –0.19).

The study adds to the evidence supporting tezepelumab as a promising new therapy, according to Muhammad Adrish, MD, who attended the poster session and was asked to comment on the study. “I think that this is a very interesting analysis in the sense that gastric reflux disease is a frequent comorbid condition that we see in patients with asthma, and a lot of these patients can have poor outcomes. When you look at the results from the data, you see that regardless of how sick they were and how much medication utilization these patients have at baseline, they still had a pretty decent response to tezepelumab. That speaks to the efficacy of that drug along a wide spectrum of patients,” said Dr. Adrish, who is an associate professor of pulmonary, critical care, and sleep medicine at Baylor College of Medicine, Houston.

The PATHWAY and NAVIGATOR studies were funded by Amgen. Dr. Lugogo has advised or consulted for AstraZeneca, Amgen, Regeneron, TEVA, Avillion, Sanofi, Novartis, Genentech, GSK, and Janssen. Dr. Adrish has no relevant financial disclosures.