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 inhalation 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.
Dr. Sebastian Canisius
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 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.
The mean FEV1 improved by 239 mL in the 1-mg AKITA group. Mean FEV1 improvements were lower in the other groups: 126 mL in the AKITA 0.5 mg budesonide group, 93 mL in the placebo group, 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, the company that 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%, respectively) and went significantly longer before an exacerbation (96 days vs. 50 days, respectively).
Inhaled budesonide therapy targeted to the small airways, on top of Global Initiative for Asthma step 5 treatment, can help patients decrease their doses of oral corticosteroids, Dr. Canisius concluded. How this works isn’t exactly clear, he added.
Dr. Canisius works for and owns stock in the company that developed the inhalation device.
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