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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03528577
• Other study ID #: CLR_17_08
• Status: Completed
• Phase: Phase 3
• Start date: September 22, 2018
• Est. completion date: August 3, 2019

Study information

• Verified date: January 2021
• Source: Sun Pharmaceutical Industries Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: August 3, 2019
• Est. primary completion date: March 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Zero-dose
Treatment A
• 90 mcg of PROAIR® HFA
Treatment B
• 180 mcg of 90 mcg of PROAIR® HFA
Treatment C
• 90 mcg of albuterol sulfate inhalation aerosol
Treatment D

Locations

Country	Name	City	State
United States	SPARC site 01	Bethesda	Maryland
United States	SPARC Site 08	Boerne	Texas
United States	SPARC Site 05	Edmond	Oklahoma
United States	SPARC Site 06	Gastonia	North Carolina
United States	SPARC Site 02	Miami Lakes	Florida
United States	SPARC Site 04	Saint Louis	Missouri
United States	SPARC Site 03	Waco	Texas
United States	SPARC Site 07	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharmaceutical Industries Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacodynamic Endpoint Post-dose PC20	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.	Approximately 15 minutes after last inhalation of study product