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NCT03528577 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Effect of of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Sun Pharmaceuticals Industries Limited)
A Phase 3 study of Asthma, sponsored by Sun Pharmaceutical Industries Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 128
- Enrollment target
- 8
- Study locations
NCT03528577 is a Phase 3 study of Asthma that has completed, run by Sun Pharmaceutical Industries Limited. The registered enrollment target is 128 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (92% lower). The trial reports 8 study locations across 7 states.
The verdict
NCT03528577, a Phase 3 study of Asthma, has completed, sponsored by Sun Pharmaceutical Industries Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 128 participants
- Enrollment target
- 8
- Study locations
Study 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
Conditions Studied
Interventions
- DRUG Zero-dose
- DRUG 90 mcg of PROAIR® HFA
- DRUG 180 mcg of 90 mcg of PROAIR® HFA
- DRUG 90 mcg of albuterol sulfate inhalation aerosol
Study Locations (8)
Texas
- SPARC Site 08 - Boerne
- SPARC Site 03 - Waco
Florida
- SPARC Site 02 - Miami Lakes
Maryland
- SPARC site 01 - Bethesda
Missouri
- SPARC Site 04 - St Louis
North Carolina
- SPARC Site 06 - Gastonia
Oklahoma
- SPARC Site 05 - Edmond
Rhode Island
- SPARC Site 07 - Warwick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2018-09-22 |
| Est. Completion | 2019-08-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03528577
The ClinicalTrials.gov registry entry for NCT03528577 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (92% lower). The listed sponsor is Sun Pharmaceutical Industries Limited, which has 38 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 4 interventions - of which Zero-dose is the first listed.
NCT03528577 reports 8 study locations spanning 7 distinct geographic areas - top geographies include Texas, Florida, Maryland.
Frequently Asked Questions
What is clinical trial NCT03528577 about?
NCT03528577 is a clinical study titled "A Study to Evaluate the Effect of of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Sun Pharmaceuticals Industries Limited)". 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
What is the current status of trial NCT03528577?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 128 participants. The study started on 2018-09-22. Estimated completion is 2019-08-03.
What conditions does trial NCT03528577 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT03528577?
The interventions under investigation include: Zero-dose (DRUG), 90 mcg of PROAIR® HFA (DRUG), 180 mcg of 90 mcg of PROAIR® HFA (DRUG), 90 mcg of albuterol sulfate inhalation aerosol (DRUG).
Who is sponsoring clinical trial NCT03528577?
This trial is sponsored by Sun Pharmaceutical Industries Limited, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03528577 being conducted?
This trial has 8 study locations across Florida, Maryland, Missouri, North Carolina, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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