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

Sun Pharma

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: 90 mcg of PROAIR® HFA; Drug: 90 mcg of albuterol sulfate inhalation aerosol; Drug: 180 mcg of 90 mcg of PROAIR® HFA; Drug: Zero-dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT03528577

CLR_17_08

Details and patient eligibility

About

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

Enrollment: 128 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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128 participants in 4 patient groups, including a placebo group

Test

Experimental group

Description:

Albuterol Sulfate Inhalation Aerosol, eq 90 mcg

Treatment:

Drug: Zero-dose

Drug: 180 mcg of 90 mcg of PROAIR® HFA

Drug: 90 mcg of albuterol sulfate inhalation aerosol

Drug: 90 mcg of PROAIR® HFA

Reference

Active Comparator group

Description:

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

Treatment:

Drug: Zero-dose

Drug: 180 mcg of 90 mcg of PROAIR® HFA

Drug: 90 mcg of albuterol sulfate inhalation aerosol

Drug: 90 mcg of PROAIR® HFA

Test Placebo

Placebo Comparator group

Description:

Placebo for Albuterol Sulfate Inhalation Aerosol

Treatment:

Drug: Zero-dose

Drug: 180 mcg of 90 mcg of PROAIR® HFA

Drug: 90 mcg of albuterol sulfate inhalation aerosol

Drug: 90 mcg of PROAIR® HFA

Reference Placebo

Placebo Comparator group

Description:

Placebo for Albuterol Sulfate Inhalation Aerosol

Treatment:

Drug: Zero-dose

Drug: 180 mcg of 90 mcg of PROAIR® HFA

Drug: 90 mcg of albuterol sulfate inhalation aerosol

Drug: 90 mcg of PROAIR® HFA