At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 128 enrolled
Drug / intervention
Zero-dose +3 moredrug
Likely dose
90 mcg of PROAIR® HFAfrom 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 Randomized, Single-Dose, Double-Blind, Double-Dummy, Four-Period, Four-Sequence, Four-Treatment, Placebo and Active Controlled, Comparative, Multiple-Center, Crossover-Design, Bronchoprovocation Study to Evaluate the Pharmacodynamic Equivalence of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Sun Pharmaceuticals Industries Limited) to PROAIR® HFA (Albuterol Sulfate) Inhalation Aerosol, eq 90 mcg Base (Teva Respiratory, LLC) in Subjects With Stable, Mild Asthma
In Brief
A Phase 3 clinical trial evaluating Zero-dose, 90 mcg of PROAIR® HFA, and 2 other interventions for Asthma. Completed, enrolled 128 participants across 8 sites.
Detailed Summary
To Evaluate the Pharmacodynamic Equivalence of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg base (Sun Pharmaceuticals Industries Limited) to PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg base (Teva Respiratory, LLC) in Subjects With Stable, Mild Asthma
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMay 2018
Enrollment StartSep 2018
Primary CompletionMar 2019
Study CompletionAug 2019
TodayJul 2026
First PostedMay 18, 2018
Enrollment StartSep 22, 2018
Primary CompletionMar 11, 2019
Study CompletionAug 3, 2019
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 8.1 years ago
Interventions
Zero-dosedrug
Treatment A
90 mcg of PROAIR® HFAdrug
Treatment B
180 mcg of 90 mcg of PROAIR® HFAdrug
Treatment C
90 mcg of albuterol sulfate inhalation aerosoldrug
Treatment D