A Study to Evaluate the Effect of of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Sun Pharmaceuticals Industries Limited)
Public ClinicalTrials.gov record NCT03528577. 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
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
Study identification
- NCT ID
- NCT03528577
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Industry
- Enrollment
- 128 participants
Conditions and interventions
Conditions
Interventions
- 180 mcg of 90 mcg of PROAIR® HFA Drug
- 90 mcg of PROAIR® HFA Drug
- 90 mcg of albuterol sulfate inhalation aerosol Drug
- Zero-dose Drug
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
- Sep 21, 2018
- Primary completion
- Mar 10, 2019
- Completion
- Aug 2, 2019
- Last update posted
- Jan 21, 2021
2018 – 2019
United States locations
- U.S. sites
- 8
- U.S. states
- 7
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| SPARC Site 02 | Miami Lakes | Florida | 33014 | — |
| SPARC site 01 | Bethesda | Maryland | 20814 | — |
| SPARC Site 04 | St Louis | Missouri | 63141 | — |
| SPARC Site 06 | Gastonia | North Carolina | 28054 | — |
| SPARC Site 05 | Edmond | Oklahoma | 73034 | — |
| SPARC Site 07 | Warwick | Rhode Island | 02886 | — |
| SPARC Site 08 | Boerne | Texas | 78006 | — |
| SPARC Site 03 | Waco | Texas | 76712 | — |
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 NCT03528577, 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 Jan 21, 2021 · Synced Apr 29, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03528577 live on ClinicalTrials.gov.