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.

NCT02624505 Phase 3 COMPLETED

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.

Details

Lead sponsor	Cipla Ltd.
Phase	Phase 3
Status	COMPLETED
Enrolment	110
Start date	2015-12
Completion	2016-11

Conditions

• Bronchial Asthma

Interventions

• 90 mcg Reference Product
• 180 mcg Reference Product
• 90 mcg Test Product
• Placebo

Primary outcomes

• Provocative Concentration of Methacholine Causing 20 % Fall (PC20) in FEV1(Forced Expiratory Volume in 1 second) — 1 day

Countries

United States