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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-22

Study Completion Date

2019-08-03

Brief Summary

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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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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Test

Albuterol Sulfate Inhalation Aerosol, eq 90 mcg

Group Type EXPERIMENTAL

Zero-dose

Intervention Type DRUG

Treatment A

90 mcg of PROAIR® HFA

Intervention Type DRUG

Treatment B

180 mcg of 90 mcg of PROAIR® HFA

Intervention Type DRUG

Treatment C

90 mcg of albuterol sulfate inhalation aerosol

Intervention Type DRUG

Treatment D

Reference

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

Group Type ACTIVE_COMPARATOR

Zero-dose

Intervention Type DRUG

Treatment A

90 mcg of PROAIR® HFA

Intervention Type DRUG

Treatment B

180 mcg of 90 mcg of PROAIR® HFA

Intervention Type DRUG

Treatment C

90 mcg of albuterol sulfate inhalation aerosol

Intervention Type DRUG

Treatment D

Test Placebo

Placebo for Albuterol Sulfate Inhalation Aerosol

Group Type PLACEBO_COMPARATOR

Zero-dose

Intervention Type DRUG

Treatment A

90 mcg of PROAIR® HFA

Intervention Type DRUG

Treatment B

180 mcg of 90 mcg of PROAIR® HFA

Intervention Type DRUG

Treatment C

90 mcg of albuterol sulfate inhalation aerosol

Intervention Type DRUG

Treatment D

Reference Placebo

Placebo for Albuterol Sulfate Inhalation Aerosol

Group Type PLACEBO_COMPARATOR

Zero-dose

Intervention Type DRUG

Treatment A

90 mcg of PROAIR® HFA

Intervention Type DRUG

Treatment B

180 mcg of 90 mcg of PROAIR® HFA

Intervention Type DRUG

Treatment C

90 mcg of albuterol sulfate inhalation aerosol

Intervention Type DRUG

Treatment D

Interventions

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Zero-dose

Treatment A

Intervention Type DRUG

90 mcg of PROAIR® HFA

Treatment B

Intervention Type DRUG

180 mcg of 90 mcg of PROAIR® HFA

Treatment C

Intervention Type DRUG

90 mcg of albuterol sulfate inhalation aerosol

Treatment D

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No