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

NCT02031640 ↗

Phase 3 Completed 1113 enrolled Teva Branded Pharmaceutical Products R&D, Inc.

RandomizedParallel-groupDouble-blindTreatment

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

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

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

Timeline

Publications

Drugs

Indications