At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 158 enrolled
Drug / intervention
Placebo MDPI +1 moredrug
Likely dose
Not stated in 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 12-week Comparison of the Efficacy and Safety of Albuterol Spiromax® Versus Placebo in Subjects 12 Years and Older With Persistent Asthma
Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Aug 29, 2011·Updated Jun 26, 2015
In Brief
A Phase 3 clinical trial evaluating Placebo MDPI and Albuterol MDPI for Asthma. Completed, enrolled 158 participants across 38 sites.
Detailed Summary
The study will measure the change in lung function in subjects with asthma after inhaling from either of two inhalers: Albuterol Spiromax® or placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 2011
Enrollment StartDec 2012
Primary CompletionOct 2013
Study CompletionNov 2013
TodayJul 2026
First PostedAug 29, 2011
Enrollment StartDec 1, 2012
Primary CompletionOct 1, 2013
Study CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 14.8 years ago
Interventions
Placebo MDPIdrug
Placebo MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.
Albuterol MDPIdrug
Albuterol MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.