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A Study to Evaluate the Effect of of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Sun Pharmaceuticals Industries Limited) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study to Evaluate the Effect of of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Sun Pharmaceuticals Industries Limited)

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

NCT03528577•Sun Pharmaceutical Industries Limited

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Men or non-pregnant women 18 to 65 years of age.
•2. Signed informed consent form that meets all criteria of current Food and Drug Administration (FDA) regulations.
•3. Females of childbearing potential must not be pregnant or lactating (as confirmed by a negative urine pregnancy test
•4. Ability to use inhalation aerosol correctly.

Exclusion Criteria

•1. Any clinically significant finding on physical exam in the opinion of the Investigator, would compromise subject's safety or data integrity.
•2. Employees of the Investigator or research center or their immediate family members.
•3. Previous participation in this study.
•4. Inability to understand the requirements of the study and the relative information and are unable or not willing to comply with the study protocol.

Locations (8)

SPARC Site 02

Miami Lakes, Florida, United States

SPARC site 01

Bethesda, Maryland, United States

SPARC Site 04

St Louis, Missouri, United States

SPARC Site 06

Gastonia, North Carolina, United States

SPARC Site 05

Edmond, Oklahoma, United States

SPARC Site 07

Warwick, Rhode Island, United States

SPARC Site 08

Boerne, Texas, United States

SPARC Site 03

Waco, Texas, United States

Key Dates

Start Date

September 22, 2018

Primary Completion Date

March 11, 2019

Completion Date

August 3, 2019

Last Updated

January 22, 2021

Enrollment

128

ACTUAL participants

Conditions

Asthma

Interventions

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

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

NCT07219173

Asthma

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RECRUITING

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

NCT02327897

Asthma

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RECRUITINGNA

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Effect of of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Sun Pharmaceuticals Industries Limited)

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma