At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 217 enrolled
Drug / intervention
placebo ProAir HFA +4 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.
Comparison of the Pharmacodynamic Profile of Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate Using Bronchoprovocation in Adult Patients With Stable Mild Asthma
In Brief
A Phase 3 clinical trial evaluating methacholine chloride, placebo ProAir HFA, and 3 other interventions for Mild Persistent Asthma. Completed, enrolled 217 participants across 17 sites.
Detailed Summary
The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMild Persistent Asthma
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 2015
Enrollment StartApr 2016
Primary CompletionAug 2016
Study CompletionSep 2016
TodayJul 2026
First PostedOct 22, 2015
Enrollment StartApr 1, 2016
Primary CompletionAug 1, 2016
Study CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 10.7 years ago
Interventions
methacholine chlorideother
placebo ProAir HFAdrug
ProAir HFAdrug
Lupin albuterol HFA MDIdrug
placebo Lupin albuterol HFA MDIdrug