BECLOMETHASONE DIPROPIONATE DELIVERED VIA BREATH-ACTUATED INHALER IN PERSISTENT ASTHMA: EFFICACY EVALUATION ACCORDING TO PRIOR TREATMENT

Introduction The treatment effect of beclomethasone dipropionate (BDP) delivered via a novel breath-actuated inhaler (BAI) was evaluated overall, and also according to pre-study therapy to see if the latter influenced efficacy. Methods This was a Phase 3, 6-week, double-blind, placebo-controlled study (NCT02513160) in 425 patients ≥12 years with persistent asthma previously treated with non-corticosteroids (NCS), inhaled corticosteroids (ICS), or ICS/long-acting beta-2 agonists. After a washout/inhaler training period, randomized patients received placebo (BAI), placebo metered-dose inhaler (MDI), BAI 320 mcg/day, BAI 640 mcg/day, or BDP MDI 320 mcg/day. Rescue medication (albuterol/salbutamol) MDI or equivalent was permitted throughout the study. Results In 425 patients, BDP BAI 320 and 640 mcg/day significantly improved baseline-adjusted trough morning forced expiratory volume in 1 second area under the effect curve from 0 to 6 weeks (FEV 1 AUEC 0–6wk ; p Conclusions Both BDP BAI doses demonstrated significant improvements in lung function overall according to the primary study endpoint; exploratory subanalysis suggests that efficacy is independent of prior asthma therapy. The safety profile of this new BDP BAI device was comparable to the established safety profile of BDP MDI, with no new safety signals.