At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 186 enrolled
Drug / intervention
Albuterol MDPI +2 moredrug
Likely dose
Albuterol MDPI 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.
A Three-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Chronic-Dose Safety and Efficacy Study of Albuterol Multi-Dose Dry Powder Inhaler (MDPI) Relative to Placebo in Pediatric Asthmatics
Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Apr 30, 2014·Updated Nov 9, 2021
In Brief
A Phase 3 clinical trial evaluating Albuterol MDPI, Placebo, and 1 other intervention for Asthma. Completed, enrolled 186 participants across 52 sites in 2 countries.
Detailed Summary
The study is to evaluate the chronic-dose efficacy and the safety of Albuterol MDPI compared to placebo in pediatric participants with asthma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesThailand, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 2014
Enrollment StartMay 2014
Primary CompletionFeb 2015
TodayJul 2026
First PostedApr 30, 2014
Enrollment StartMay 1, 2014
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 12.2 years ago
Interventions
Albuterol MDPIdrug
90 mcg/actuation of the multidose dry powder inhaler (MDPI).
Placebodrug
Matching Placebo delivered via a multidose dry powder inhaler (MDPI).
ProAir HFA inhalerdrug
Rescue medication, ProAir hydrofluoroalkane (HFA) inhaler, was dispensed at the run-in visit for the relief of asthma symptoms to be administered as needed.