At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 160 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 and Steady-State Pharmacokinetics of Albuterol Spiromax® Versus Placebo in Subjects 12 Years and Older With Persistent Asthma
Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Dec 11, 2012·Updated Jun 26, 2015
In Brief
A Phase 3 clinical trial evaluating Placebo MDPI and Albuterol MDPI for Asthma. Completed, enrolled 160 participants across 35 sites.
Detailed Summary
The primary objective of this study is to evaluate the efficacy of Albuterol Spiromax® versus placebo in subjects with persistent asthma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2012
First PostedDec 2012
Primary CompletionOct 2013
Study CompletionNov 2013
TodayJul 2026
First PostedDec 11, 2012
Enrollment StartDec 1, 2012
Primary CompletionOct 1, 2013
Study CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.6 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.