At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 364 enrolled
Drug / intervention
Placebo MDPI +1 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 Multi-Center 52-Week Study to Assess the Safety of Albuterol Spiromax® in Subjects With Asthma
Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Oct 3, 2012·Updated Aug 19, 2015
In Brief
A Phase 3 clinical trial evaluating Placebo MDPI and Albuterol MDPI for Asthma. Completed, enrolled 364 participants across 30 sites.
Detailed Summary
The purpose of this study is to evaluate the safety of Albuterol Spiromax® over 52 weeks during two dosing periods: (1) a 12-week, double-blind, placebo-controlled QID dosing period followed by (2) a 40-week, open-label PRN dosing period, and to evaluate Albuterol Spiromax® device performance through the life of the device during the study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2012
First PostedOct 2012
Primary CompletionDec 2013
TodayJul 2026
First PostedOct 3, 2012
Enrollment StartOct 1, 2012
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 13.7 years ago
Interventions
Placebo MDPIdrug
Placebo MDPI (multi-dose dry powder inhaler) to match the active intervention.
Albuterol MDPIdrug
Albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation.