Study to Assess the Efficacy & Safety of Beclomethasone Dipropionate in

Status Completed

Clinical Trial Summary

The primary objective of this study is to evaluate the efficacy of beclomethasone dipropionate administered via BAI at a dose strength of 40 or 80 mcg per oral inhalation (320 or 640 mcg/day, respectively) compared with placebo treatment in patients with persistent asthma as assessed by the standardized baseline-adjusted trough morning (pre-dose and pre-rescue bronchodilator) forced expiratory volume in 1 second (FEV1) area under the effect curve from time 0 to 6 weeks (AUEC[0-6wk]).

Clinical Trial Description

Run-In Period (Days -14 to Day -1): Participants were provided with single-blind placebo breath-actuated inhaler (BAI) or metered-dose inhaler (MDI) device for twice-daily use after appropriate training and demonstration of the proper technique. Participants discontinued their current asthma therapy for the duration of the study. Treatment Period (Day 0 to Week 6): Participants were randomly assigned to treatment and device type through a qualified randomization service provider (ie, IRT). The interactive response technology (IRT) system stratified patients based on treatment at the time of screening visit, either inhaled corticosteroid (ICS) or non-corticosteroid (NCS). During the study, blinded persons were blinded to treatment (active or placebo) assigned but not device (BAI or MDI) assignment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02513160
Study type	Interventional
Source	Teva Branded Pharmaceutical Products R&D, Inc.
Contact
Status	Completed
Phase	Phase 3
Start date	September 30, 2015
Completion date	March 31, 2016

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Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms