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Completed

NCT Number: NCT03528577

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

SPARC Site 02, Miami Lakes, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Zero-dose

Drug

Treatment A

90 mcg of PROAIR® HFA

Drug

Treatment B

180 mcg of 90 mcg of PROAIR® HFA

Drug

Treatment C

90 mcg of albuterol sulfate inhalation aerosol

Drug

Treatment D

Primary outcomes

  1. Pharmacodynamic Endpoint Post-dose PC20

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries Limited

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 18, 2018
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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