Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma
Public ClinicalTrials.gov record NCT02584257. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT02584257
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 217 participants
Conditions and interventions
Conditions
Interventions
- methacholine chloride Other
- placebo ProAir HFA Drug
- ProAir HFA Drug
- Lupin albuterol HFA MDI Drug
- placebo Lupin albuterol HFA MDI Drug
Other · Drug
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2016
- Primary completion
- Jul 31, 2016
- Completion
- Aug 31, 2016
- Last update posted
- Dec 3, 2020
2016
United States locations
- U.S. sites
- 17
- U.S. states
- 11
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Research Center Site #110 | Huntington Beach | California | 92647 | — |
| Investigational Research Center Site #114 | Mission Viejo | California | 92691 | — |
| Investigational Research Center Site #113 | Rolling Hills Estates | California | 90274 | — |
| Investigational Research Center Site #112 | San Diego | California | 92123 | — |
| Investigational Research Center Site #116 | San Jose | California | 95117 | — |
| Investigational Research Center Site #106 | Tallahassee | Florida | 32308 | — |
| Investigational Research Center Site #109 | Baltimore | Maryland | 21236 | — |
| Investigational Research Center Site #105 | Bethesda | Maryland | 20814 | — |
| Investigational Research Center Site #103 | North Dartmouth | Massachusetts | 02747 | — |
| Investigational Research Center Site #108 | St Louis | Missouri | 63141 | — |
| Investigational Research Center Site #115 | Bellevue | Nebraska | 68123 | — |
| Investigational Research Center Site #104 | Skillman | New Jersey | 08558 | — |
| Investigational Research Center Site #102 | Raleigh | North Carolina | 27607 | — |
| Investigational Research Center Site #111 | Cincinnati | Ohio | 45231 | — |
| Investigational Research Center Site #118 | Tulsa | Oklahoma | 74136 | — |
| Investigational Research Center Site #101 | Medford | Oregon | 97504 | — |
| Investigational Research Center Site #107 | Portland | Oregon | 97202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02584257, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 3, 2020 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02584257 live on ClinicalTrials.gov.