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

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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

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

Trial documents
2

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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