At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 1,113 enrolled

Drug / intervention

Beclomethasone dipropionate +2 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/NCT02031640

NCT02031640Phase 3Completed

Compare CT.gov

A Randomized, Double-Blind, Double-Dummy, Placebo Controlled, Parallel-Group, 12-Week Clinical Study to Assess the Efficacy and Safety of 320 or 640 mcg/Day of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma

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

In Brief

A Phase 3 clinical trial evaluating Beclomethasone dipropionate, Placebo, and 1 other intervention for Asthma. Completed, enrolled 1,113 participants across 131 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAsthma

CountriesGermany, Hungary, Poland, United States

Collaborators--

Timeline

Phase 3CompletedFinished

2014201520162017201820192020202120222023202420252026

Enrollment StartDec 2013

First PostedJan 2014

Primary CompletionNov 2014

Study CompletionDec 2014

TodayJul 2026

First PostedJan 9, 2014

Enrollment StartDec 1, 2013

Primary CompletionNov 1, 2014

Study CompletionDec 1, 2014

TodayJul 2, 2026

Enrollment to primary: 11 monthsPosted 12.5 years ago

Interventions

Beclomethasone dipropionatedrug

Placebodrug

Albuterol/salbutamoldrug

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.