Trials / Completed
CompletedNCT02584257
Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 217 (actual)
- Sponsor
- Lupin, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
A Multicenter, Double-Blind, Double-Dummy, Placebo-Controlled, 5-Treatment, Randomized, Crossover Study to Demonstrate the Pharmacodynamic Bioequivalence of Test and Reference Metered Dose Inhalers containing Albuterol Sulfate using Bronchoprovocation in Adult Patients with Stable Mild Asthma
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | methacholine chloride | |
| DRUG | placebo ProAir HFA | |
| DRUG | ProAir HFA | |
| DRUG | Lupin albuterol HFA MDI | |
| DRUG | placebo Lupin albuterol HFA MDI |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2016-08-01
- Completion
- 2016-09-01
- First posted
- 2015-10-22
- Last updated
- 2020-12-04
- Results posted
- 2020-11-18
Locations
17 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02584257. Inclusion in this directory is not an endorsement.