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

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami Lakes, Florida, United States, 33014
      • SPARC Site 02
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • SPARC Site 01
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • SPARC Site 04
  • North Carolina
    • Gastonia, North Carolina, United States, 28054
      • SPARC Site 06
  • Oklahoma
    • Edmond, Oklahoma, United States, 73034
      • SPARC Site 05
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • SPARC Site 07
  • Texas
    • Boerne, Texas, United States, 78006
      • SPARC Site 08
    • Waco, Texas, United States, 76712
      • SPARC Site 03

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Test; Albuterol Sulfate Inhalation Aerosol, eq 90 mcg	Drug: Zero-dose; Treatment A; Drug: 90 mcg of PROAIR® HFA; Treatment B; Drug: 180 mcg of 90 mcg of PROAIR® HFA; Treatment C; Drug: 90 mcg of albuterol sulfate inhalation aerosol; Treatment D
ACTIVE_COMPARATOR: Reference; PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg	Drug: Zero-dose; Treatment A; Drug: 90 mcg of PROAIR® HFA; Treatment B; Drug: 180 mcg of 90 mcg of PROAIR® HFA; Treatment C; Drug: 90 mcg of albuterol sulfate inhalation aerosol; Treatment D
PLACEBO_COMPARATOR: Test Placebo; Placebo for Albuterol Sulfate Inhalation Aerosol	Drug: Zero-dose; Treatment A; Drug: 90 mcg of PROAIR® HFA; Treatment B; Drug: 180 mcg of 90 mcg of PROAIR® HFA; Treatment C; Drug: 90 mcg of albuterol sulfate inhalation aerosol; Treatment D
PLACEBO_COMPARATOR: Reference Placebo; Placebo for Albuterol Sulfate Inhalation Aerosol	Drug: Zero-dose; Treatment A; Drug: 90 mcg of PROAIR® HFA; Treatment B; Drug: 180 mcg of 90 mcg of PROAIR® HFA; Treatment C; Drug: 90 mcg of albuterol sulfate inhalation aerosol; Treatment D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sun Pharmaceutical Industries Limited

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 22, 2018
• Primary Completion (ACTUAL): March 11, 2019
• Study Completion (ACTUAL): August 3, 2019

Study Registration Dates

• First Submitted: April 21, 2018
• First Submitted That Met QC Criteria: May 4, 2018
• First Posted (ACTUAL): May 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 2, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Sympathomimetics; Albuterol; Procaterol
• Other Study ID Numbers: CLR_17_08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No