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

Bronchial Asthma Clinical Trial

Official title:
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.

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06154304
Study type Interventional
Source Cipla Ltd.
Contact Brijesh Wadekar, Doctor
Phone 09927971349
Email brijesh.wadekar@cipla.com
Status Not yet recruiting
Phase Phase 3
Start date December 11, 2023
Completion date September 23, 2024
View Details
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