A 12-week Safety and Efficacy Study of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Patients >=12 Years Old With Persistent Asthma

Summary

This is a randomized, double-blind, placebo-controlled parallel-group study. Participants will be randomly assigned to receive treatment with beclomethasone dipropionate at a dosage of 80 or 160 mcg/day delivered via a Breath-Actuated Inhaler (BAI); or a matching BAI placebo, in a 1:1:1 ratio after a 14- to 21-day run-in period. Participants and investigators will remain blinded to randomized treatment assignment during the study

Timeline

Start

2013-12-26

Primary completion

2014-12-24

Completion

2014-12-24

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo BAI vs BDP 160 mcg BAI; p = 0.0010; LSM difference 0.116 (95% CI 0.048 to 0.185); ANCOVA; NCT02040779 ↗

registry analysis (superiority test); Placebo BAI vs BDP 80 mcg BAI; p = 0.0005; LSM difference 0.124 (95% CI 0.054 to 0.193); ANCOVA; NCT02040779 ↗

Publications

• Hampel FC Jr, Carr W, Gillespie M, Small CJ. Evaluation of beclomethasone dipropionate (80 and 160 micrograms/day) delivered via a breath-actuated inhaler for persistent asthma. Allergy Asthma Proc. 2017 Nov 8;38(6):419-430. doi: 10.2500/aap.2017.38.4089. Epub 2017 Sep 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	beclomethasone dipropionate	Other / unclassified	80 ug	Inhaled
Subject	beclomethasone dipropionate	Other / unclassified	160 ug	Inhaled
Background	Salbutamol	Unknown	—	Inhaled

Indications