NCT02624505

Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate 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: 110 (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	90 mcg Reference Product	Drug: 90 mcg Reference Product
DRUG	180 mcg Reference Product	Drug: 180 mcg of Reference Product
DRUG	90 mcg Test Product	Drug: 90 mcg of Test Product
DRUG	Placebo	Placebo Product

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-10-01
• Completion: 2016-11-01
• First posted: 2015-12-08
• Last updated: 2019-07-25

Locations

1 site across 1 country: United States