NCT03528577

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Sun Pharmaceutical Industries Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Asthma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-09-22
• Primary completion: 2019-03-11
• Completion: 2019-08-03
• First posted: 2018-05-18
• Last updated: 2021-01-22
• Results posted: 2021-01-22

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study