At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 6-Week Clinical Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) at 320 or 640 mcg/Day in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma
In Brief
A Phase 3 clinical trial evaluating Beclomethasone Dipropionate 640, Placebo, and 3 other interventions for Persistent Asthma. Completed, enrolled 713 participants across 75 sites.
Detailed 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\[0-6wk\]).
Study Details
Timeline
Interventions
Beclomethasone Dipropionate 640 mcg BAI
Placebo, taken in the morning and evening each day, was provided in matching BAI and MDI devices. The placebo devices were identical to the devices used to deliver active drug.
Beclomethasone dipropionate treatment administered via breath-actuated inhaler (BAI) (320 mcg/day).
Each patient's current rescue medication was replaced with study-supplied albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent during the run-in and double-blind study periods.
Beclomethasone dipropionate treatment administered via metered-dose inhaler (MDI) (320 mcg/day).