NCT06154304

BE Study of Albuterol Sulfate Inhalation Aerosol 90 mcg Per Actuation in Patients With Stable Mild Asthma

To Compare the Bronchoprotective Effects of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate Using Methacholine Bronchoprovocation Challenge Testing in Stable Mild Asthma Patients.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Cipla Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.

Detailed description

This study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in terms of FEV1 measured at different time-points, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.

Conditions

• Bronchial Asthma

Interventions

Type	Name	Description
DRUG	Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation)	90 mcg
DRUG	Ventolin HFA 90Mcg/Actuation Inhalation Aerosol_#1	90 mcg
DRUG	Ventolin HFA, 90 Mcg/Inh Inhalation Aerosol_#2	180 mcg
DRUG	Placebo	Placebo

Timeline

• Start date: 2023-12-06
• Primary completion: 2024-09-16
• Completion: 2024-11-29
• First posted: 2023-12-04
• Last updated: 2025-07-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study