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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Zero-dose
90 mcg of PROAIR® HFA
180 mcg of 90 mcg of PROAIR® HFA
90 mcg of albuterol sulfate inhalation aerosol
Sponsored by
Sun Pharmaceutical Industries Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • SPARC Site 02
  • SPARC site 01
  • SPARC Site 04
  • SPARC Site 06
  • SPARC Site 05
  • SPARC Site 07
  • SPARC Site 08
  • SPARC Site 03

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Test

Reference

Test Placebo

Reference Placebo

Arm Description

Albuterol Sulfate Inhalation Aerosol, eq 90 mcg

PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg

Placebo for Albuterol Sulfate Inhalation Aerosol

Placebo for Albuterol Sulfate Inhalation Aerosol

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 21, 2018
Last Updated
January 2, 2021
Sponsor
Sun Pharmaceutical Industries Limited
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1. Study Identification

Unique Protocol Identification Number
NCT03528577
Brief Title
A Study to Evaluate the Effect of of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Sun Pharmaceuticals Industries Limited)
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 22, 2018 (Actual)
Primary Completion Date
March 11, 2019 (Actual)
Study Completion Date
August 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharmaceutical Industries Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test
Arm Type
Experimental
Arm Description
Albuterol Sulfate Inhalation Aerosol, eq 90 mcg
Arm Title
Reference
Arm Type
Active Comparator
Arm Description
PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg
Arm Title
Test Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for Albuterol Sulfate Inhalation Aerosol
Arm Title
Reference Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for Albuterol Sulfate Inhalation Aerosol
Intervention Type
Drug
Intervention Name(s)
Zero-dose
Intervention Description
Treatment A
Intervention Type
Drug
Intervention Name(s)
90 mcg of PROAIR® HFA
Intervention Description
Treatment B
Intervention Type
Drug
Intervention Name(s)
180 mcg of 90 mcg of PROAIR® HFA
Intervention Description
Treatment C
Intervention Type
Drug
Intervention Name(s)
90 mcg of albuterol sulfate inhalation aerosol
Intervention Description
Treatment D
Primary Outcome Measure Information:
Title
Pharmacodynamic Endpoint Post-dose PC20
Description
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.
Time Frame
Approximately 15 minutes after last inhalation of study product

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
SPARC Site 02
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
SPARC site 01
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
SPARC Site 04
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
SPARC Site 06
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
SPARC Site 05
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Facility Name
SPARC Site 07
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
SPARC Site 08
City
Boerne
State/Province
Texas
ZIP/Postal Code
78006
Country
United States
Facility Name
SPARC Site 03
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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