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

Phase 3

Completed

• Conditions: Asthma
• 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

• Registration Number: NCT03528577
• Lead Sponsor: Sun Pharmaceutical Industries Limited

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-21
• Study First Submitted QC: 2018-05-04
• Study First Posted: 2018-05-18
• Study Start: 2018-09-22
• Primary Completion: 2019-03-11
• Study Completion: 2019-08-03
• Results First Submitted: 2020-07-18
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-02
• Last Update Submitted: 2021-01-02
• Results First Posted: 2021-01-22
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test	90 mcg of albuterol sulfate inhalation aerosol	Albuterol Sulfate Inhalation Aerosol, eq 90 mcg
Reference Placebo	90 mcg of albuterol sulfate inhalation aerosol	Placebo for Albuterol Sulfate Inhalation Aerosol
Reference	Zero-dose	PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg
Test Placebo	90 mcg of PROAIR® HFA	Placebo for Albuterol Sulfate Inhalation Aerosol
Reference Placebo	180 mcg of 90 mcg of PROAIR® HFA	Placebo for Albuterol Sulfate Inhalation Aerosol
Test Placebo	Zero-dose	Placebo for Albuterol Sulfate Inhalation Aerosol
Reference Placebo	90 mcg of PROAIR® HFA	Placebo for Albuterol Sulfate Inhalation Aerosol
Test	Zero-dose	Albuterol Sulfate Inhalation Aerosol, eq 90 mcg
Test	180 mcg of 90 mcg of PROAIR® HFA	Albuterol Sulfate Inhalation Aerosol, eq 90 mcg
Reference	90 mcg of albuterol sulfate inhalation aerosol	PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg
Test	90 mcg of PROAIR® HFA	Albuterol Sulfate Inhalation Aerosol, eq 90 mcg
Reference	90 mcg of PROAIR® HFA	PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg
Reference	180 mcg of 90 mcg of PROAIR® HFA	PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg
Test Placebo	90 mcg of albuterol sulfate inhalation aerosol	Placebo for Albuterol Sulfate Inhalation Aerosol
Test Placebo	180 mcg of 90 mcg of PROAIR® HFA	Placebo for Albuterol Sulfate Inhalation Aerosol
Reference Placebo	Zero-dose	Placebo for Albuterol Sulfate Inhalation Aerosol

Primary Outcome Measures

Name	Time	Method
Pharmacodynamic Endpoint Post-dose PC20	Approximately 15 minutes after last inhalation of study product	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.

Trial Locations

Locations (8)

SPARC Site 04; 🇺🇸 Saint Louis, Missouri, United States

SPARC Site 02; 🇺🇸 Miami Lakes, Florida, United States

SPARC site 01; 🇺🇸 Bethesda, Maryland, 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

SPARC Site 06; 🇺🇸 Gastonia, North Carolina, United States