CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 628 enrolled
Drug / intervention
Beclomethasone dipropionate BAI +4 moredrug
Likely dose
albuterol/salbutamol 90 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02040766
NCT02040766Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, 12-Week Clinical Study to Assess the Efficacy and Safety of 80 or 160 mcg/Day of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Pediatric Patients 4 Through 11 Years of Age With Persistent Asthma

Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Jan 20, 2014·Updated Nov 9, 2021

In Brief

A Phase 3 clinical trial evaluating Beclomethasone dipropionate BAI, Placebo BAI, and 3 other interventions for Asthma. Completed, enrolled 628 participants across 102 sites in 5 countries.

Detailed Summary

This randomized, double-blind, double-dummy, placebo-controlled, parallel-group, 12-week study will evaluate the efficacy and safety of beclomethasone dipropionate (80 or 160 mcg/day) administered via breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) in pediatric patients 4 through 11 years of age with persistent asthma, compared with placebo. Patients took 1 inhalation (with assistance from parents/guardians/caregivers, as needed) from each of 2 devices (BAI device followed by MDI device in that order) twice daily as per the double-dummy study design: 1 BAI treatment or placebo device and 1 MDI treatment or placebo device for a total of 2 inhalations each time.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesCroatia, Mexico, Poland, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 20, 2014
Enrollment StartDec 1, 2013
Primary CompletionFeb 1, 2016
Study CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 12.5 years ago

Interventions

Beclomethasone dipropionate BAIdrug

Beclomethasone dipropionate (BDP), was delivered by a single inhalation using a breath-actuated inhaler (BAI) at levels of 40 mcg or 80 mcg per inhalation, twice each day.

Placebo BAIdrug

Placebo was delivered by a single inhalation using a breath-actuated inhaler (BAI) twice each day.

albuterol/salbutamol 90 mcgdrug

Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.

Beclomethasone dipropionate MDIdrug

Beclomethasone dipropionate (BDP), was delivered by a single inhalation using a metered-dose inhaler (MDI) at levels of 40 mcg or 80 mcg per inhalation, twice each day.

Placebo MDIdrug

Placebo was delivered by a single inhalation using a metered-dose inhaler (MDI) twice each day.