ATLANTA, GA—Findings of a Phase 3 study (NCT02513160) presented at the 2017 AAAAI Annual Meeting indicated that beclomethasone dipropionate (BDP) administered via a breath-actuated inhaler (BAI) does not only have superior efficacy compared to placebo but also has a similar efficacy and safety profile to BDP administered via a metered-dose inhaler (MDI).
Qvar Inhalation Aerosol is an FDA-approved inhaled corticosteroid that delivers BDP via a pressurized MDI; it produces an extrafine aerosol with a small particle size. A new BAI is currently under development and uses the same BDP formulation that does not require hand-breath coordination for drug delivery.
Patients ≥12 years old with persistent asthma were included in this 6-week, double-blind study. The first phase of the study included a 14- to 30-day, single-blind run-in period where patients discontinued all asthma medications and were provided with albuterol MDI as needed for rescue and placebo BAI or MDI twice daily for training purposes. Next, BAI patients were randomized and received BDP BAI 320mcg/day, BDP BAI 640mcg/day, or placebo BAI. MDI patients were also randomized and received either BDP MDI 320mcg/day or placebo MDI.
The primary endpoint of the study was standardized baseline-adjusted trough morning forced expiratory volume in 1 second area under the effect curve measured from 0 to 6 weeks (FEV1AUEC0-6wk). Other assessments included morning peak expiratory flow (PEF), trough morning FEV1, use of rescue medications, asthma symptoms, withdrawals from the study, and tolerability.
A total of 425 patients were included in both the modified intention-to-treat and safety analyses. Results indicated that both doses of BDP BAI significantly improved FEV1AUEC0-6wk compared to placebo (P<0.0001). Significant improvement was also seen in the BAI treatment groups compared to placebo for morning PEF, use of rescue medications, and asthma symptoms (P≤0.0003). Results of the study also found similar treatment effects in patients using BDP MDI (P≤0.0006).
Additionally, fewer patients withdrew from the study due to worsening asthma in the BDP BAI and MDI treatment groups vs. placebo (0 or 1 patient in the BDP treatment groups vs. 10 patients in the placebo group). Treatment with BDP BAI was also well tolerated among patients. There were 19 total asthma exacerbations reported, “with a considerably higher incidence in the placebo group vs. the active treatment group,” noted study author Nancy Ostrom, MD, CPI, of Allergy and Asthma Medical Group & Research Center, in San Diego, CA.
Dr. Ostrom and coauthors concluded, “BDP BAI demonstrated significant improvements in pulmonary function and overall asthma control relative to placebo. The safety profile of BDP BAI was comparable to the established profile of BDP MDI, with no new safety signals.”