A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants >=12 Years Old With Persistent Asthma

Summary

This is a Phase 3, randomized, placebo-controlled, double-blind,double-dummy, parallel-group, 12-week study in male and female patients, 12 years of age and older, with persistent asthma.

Timeline

Start

2013-12

Primary completion

2014-11

Completion

2014-12

Outcome

Missed primary endpoint

registry Placebo BAI and MDI vs BDP 320 mcg BAI; p = 0.272 NCT02031640 ↗

registry Placebo BAI and MDI vs BDP 640 mcg BAI; p = 0.1415 NCT02031640 ↗

paper Baseline-adjusted trough morning forced expiratory volume in 1 second area under the effect curve from time 0 to 12 weeks (primary end point) was increased in the BAI 320 and BAI 640 μg/day groups and the MDI 640 μg/day group versus placebo (not significant). PMID 27510595 ↗

Publications

• Amar NJ, Moss MH, Kerwin EM, Li J, Small CJ. Safety and efficacy of beclomethasone dipropionate delivered by breath-actuated or metered-dose inhaler for persistent asthma. Allergy Asthma Proc. 2016 Sep;37(5):359-69. doi: 10.2500/aap.2016.37.3983. Epub 2016 Aug 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	beclomethasone dipropionate	Other / unclassified	320 ug	Inhaled
Subject	beclomethasone dipropionate	Other / unclassified	640 ug	Inhaled
Background	Salbutamol	Unknown	90 ug	Inhaled

Indications