drugset / Trial / NCT06154304

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

NCT06154304

Phase 3 Completed 120 enrolled Cipla Ltd.
RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start
2023-12-06
Primary completion
2024-09-16
Completion
2024-11-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Salbutamol Unknown 90 ug Inhaled
Subject Salbutamol Unknown 180 ug Inhaled

Indications