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SAN DIEGO – Adults on chronic oral corticosteroids for asthma were able to decrease their doses while maintaining lung function by adding 0.5-1 mg budesonide delivered by an experimental inhaler in a randomized study of 199 patients.
The four-arm phase II/III study compared 18 weeks of twice-daily treatment using the AKITA® inhalation system or a conventional nebulizer while tapering oral corticosteroids. The compressor-driven system is designed to deliver the budesonide suspension to the small airways of the lungs. It is not approved in the United States to treat adults with asthma.
The system delivered budesonide 1 mg, budesonide 0.5 mg, or placebo, compared with an open-label treatment group that used a nebulizer to deliver 1 mg budesonide. Oral corticosteroids were tapered to week 14. Patients were followed to week 20, with lung function parameters measures every 2 weeks.
The mean forced expiratory volume at 1 second (FEV1) significantly improved in the AKITA 1-mg budesonide group, compared with baseline, Dr. Sebastian Canisius and his associates reported at an international conference of the American Thoracic Society.
Mean FEV1 improved by 239 mL in the 1-mg AKITA group; improvements were lower in the other groups: 126 mL in the AKITA 0.5-mg budesonide group, 93 mL for placebo, and 137 mL in the nebulizer group.
Another surrogate marker of small airway function improved significantly in the AKITA 1-mg group compared with the placebo group – forced expiratory flow 25%-75% of vital capacity, or FEF (25-75), said Dr. Canisius, director of clinical development and drug safety for the Vectura Group, Kassel Area, Germany, which developed the inhalation system.
The FEF (25-75) improved by a mean of 0.2 L/s, compared with baseline in the AKITA 1-mg group, and did not change in the placebo group. Improvements in the other two groups were smaller and not significant compared with placebo.
Patients in the AKITA 1-mg group were significantly less likely to develop an asthma exacerbation, compared with the nebulizer group (8% vs. 22%) and went significantly longer before an exacerbation (96 days vs. 50 days).
Dr. Canisius works for and owns stock in the company that developed the inhalation device.
Dr. Daniel Ouellette, FCCP, comments: Physicians caring for patients with severe asthma frequently encounter patients who require oral corticosteroid therapy despite being treated with significant complex inhaled regimens. The new AKITA® inhalation system is designed to deliver an aerosol more effectively to the distal airways than traditional nebulizers or handheld inhalant devices. In a recent trial, when compared to budesonide delivered by a traditional nebulizer, use of the system was associated with improvements in spirometric measures, reduction in the number of occurrences of asthma exacerbations, and increased length of time between recurrent exacerbations. The adverse consequences of long-term oral corticosteroid use will make the AKITA system an attractive adjunct to asthma management, if it can be demonstrated that the oral corticosteroid dose can be reduced, or their use eliminated, in severe asthma patients. However, long-term studies will be necessary to determine if there is significant systemic absorption, and thus risk of attendant consequences, of corticosteroids when administered by this device. 
Dr. Daniel Ouellette
Dr. Daniel Ouellette, FCCP, comments: Physicians caring for patients with severe asthma frequently encounter patients who require oral corticosteroid therapy despite being treated with significant complex inhaled regimens. The new AKITA® inhalation system is designed to deliver an aerosol more effectively to the distal airways than traditional nebulizers or handheld inhalant devices. In a recent trial, when compared to budesonide delivered by a traditional nebulizer, use of the system was associated with improvements in spirometric measures, reduction in the number of occurrences of asthma exacerbations, and increased length of time between recurrent exacerbations. The adverse consequences of long-term oral corticosteroid use will make the AKITA system an attractive adjunct to asthma management, if it can be demonstrated that the oral corticosteroid dose can be reduced, or their use eliminated, in severe asthma patients. However, long-term studies will be necessary to determine if there is significant systemic absorption, and thus risk of attendant consequences, of corticosteroids when administered by this device. Dr. Daniel Ouellette
Dr. Daniel Ouellette, FCCP, comments: Physicians caring for patients with severe asthma frequently encounter patients who require oral corticosteroid therapy despite being treated with significant complex inhaled regimens. The new AKITA® inhalation system is designed to deliver an aerosol more effectively to the distal airways than traditional nebulizers or handheld inhalant devices. In a recent trial, when compared to budesonide delivered by a traditional nebulizer, use of the system was associated with improvements in spirometric measures, reduction in the number of occurrences of asthma exacerbations, and increased length of time between recurrent exacerbations. The adverse consequences of long-term oral corticosteroid use will make the AKITA system an attractive adjunct to asthma management, if it can be demonstrated that the oral corticosteroid dose can be reduced, or their use eliminated, in severe asthma patients. However, long-term studies will be necessary to determine if there is significant systemic absorption, and thus risk of attendant consequences, of corticosteroids when administered by this device. Dr. Daniel Ouellette
SAN DIEGO – Adults on chronic oral corticosteroids for asthma were able to decrease their doses while maintaining lung function by adding 0.5-1 mg budesonide delivered by an experimental inhaler in a randomized study of 199 patients.
The four-arm phase II/III study compared 18 weeks of twice-daily treatment using the AKITA® inhalation system or a conventional nebulizer while tapering oral corticosteroids. The compressor-driven system is designed to deliver the budesonide suspension to the small airways of the lungs. It is not approved in the United States to treat adults with asthma.
The system delivered budesonide 1 mg, budesonide 0.5 mg, or placebo, compared with an open-label treatment group that used a nebulizer to deliver 1 mg budesonide. Oral corticosteroids were tapered to week 14. Patients were followed to week 20, with lung function parameters measures every 2 weeks.
The mean forced expiratory volume at 1 second (FEV1) significantly improved in the AKITA 1-mg budesonide group, compared with baseline, Dr. Sebastian Canisius and his associates reported at an international conference of the American Thoracic Society.
Mean FEV1 improved by 239 mL in the 1-mg AKITA group; improvements were lower in the other groups: 126 mL in the AKITA 0.5-mg budesonide group, 93 mL for placebo, and 137 mL in the nebulizer group.
Another surrogate marker of small airway function improved significantly in the AKITA 1-mg group compared with the placebo group – forced expiratory flow 25%-75% of vital capacity, or FEF (25-75), said Dr. Canisius, director of clinical development and drug safety for the Vectura Group, Kassel Area, Germany, which developed the inhalation system.
The FEF (25-75) improved by a mean of 0.2 L/s, compared with baseline in the AKITA 1-mg group, and did not change in the placebo group. Improvements in the other two groups were smaller and not significant compared with placebo.
Patients in the AKITA 1-mg group were significantly less likely to develop an asthma exacerbation, compared with the nebulizer group (8% vs. 22%) and went significantly longer before an exacerbation (96 days vs. 50 days).
Dr. Canisius works for and owns stock in the company that developed the inhalation device.
SAN DIEGO – Adults on chronic oral corticosteroids for asthma were able to decrease their doses while maintaining lung function by adding 0.5-1 mg budesonide delivered by an experimental inhaler in a randomized study of 199 patients.
The four-arm phase II/III study compared 18 weeks of twice-daily treatment using the AKITA® inhalation system or a conventional nebulizer while tapering oral corticosteroids. The compressor-driven system is designed to deliver the budesonide suspension to the small airways of the lungs. It is not approved in the United States to treat adults with asthma.
The system delivered budesonide 1 mg, budesonide 0.5 mg, or placebo, compared with an open-label treatment group that used a nebulizer to deliver 1 mg budesonide. Oral corticosteroids were tapered to week 14. Patients were followed to week 20, with lung function parameters measures every 2 weeks.
The mean forced expiratory volume at 1 second (FEV1) significantly improved in the AKITA 1-mg budesonide group, compared with baseline, Dr. Sebastian Canisius and his associates reported at an international conference of the American Thoracic Society.
Mean FEV1 improved by 239 mL in the 1-mg AKITA group; improvements were lower in the other groups: 126 mL in the AKITA 0.5-mg budesonide group, 93 mL for placebo, and 137 mL in the nebulizer group.
Another surrogate marker of small airway function improved significantly in the AKITA 1-mg group compared with the placebo group – forced expiratory flow 25%-75% of vital capacity, or FEF (25-75), said Dr. Canisius, director of clinical development and drug safety for the Vectura Group, Kassel Area, Germany, which developed the inhalation system.
The FEF (25-75) improved by a mean of 0.2 L/s, compared with baseline in the AKITA 1-mg group, and did not change in the placebo group. Improvements in the other two groups were smaller and not significant compared with placebo.
Patients in the AKITA 1-mg group were significantly less likely to develop an asthma exacerbation, compared with the nebulizer group (8% vs. 22%) and went significantly longer before an exacerbation (96 days vs. 50 days).
Dr. Canisius works for and owns stock in the company that developed the inhalation device.
Key clinical point: A novel inhaler that targets small airways can improve budesonide delivery.
Major finding: The mean FEV1 improved significantly in the AKITA 1-mg budesonide group (by 239 mL) compared with baseline.
Data source: A randomized, four-arm, parallel-group, placebo-controlled trial comparing budesonide delivery methods in 199 patients.
Disclosures: The study presenter is an employee of and investor in the company that developed the inhalation device.
