Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Asthma, sponsored by Sun Pharmaceutical Industries Limited.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The primary pharmacodynamic endpoint is the post-dose PC20, which is the provocative concentration of methacholine challenge agent required to reduce the forced expiry volume in one second (FEV1) by 20%, following the administration of different doses of albuterol (or placebo) by inhalation. Primary analysis group -pharmacodynamic population.
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 |
What the finished NCT03528577 record still lists
NCT03528577 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (92% lower).
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 lists 8 locations in 7 states (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.
Learn More About Clinical Trials
Similar trials for Asthma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03528577's enrollment target sits among peer trials
128 195th of 374 higher than 180 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Depemokimab Asthma Imaging and Bronchoscopy Sub-Study
RECRUITING · Phase 3
-
Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma
RECRUITING · Phase 3
-
A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma
RECRUITING · Phase 3
-
A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma
RECRUITING · Phase 3
-
Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)
RECRUITING · Phase 3
-
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma (DOMINICA)
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02870738 · 128 participants · Phase 2
Bladder Directed vs. Pelvic Floor Therapy in IC/BPS
- NCT03294460 · 128 participants · Phase 1
Nicotinic Receptor Genetic Variation and Alcohol Reward
- NCT04149977 · 128 participants · NA
Blood Flow Restriction Therapy in Lower Limb Extensor Injuries
- NCT04373057 · 128 participants · Phase 1
Prebiotic Galacto-oligosaccharide and Acute GVHD
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI