Comparison of the Pharmacodynamic Profile of Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate Using Bronchoprovocation in Adult Patients With Stable Mild Asthma

NCT02584257 Phase 3 COMPLETED Results posted

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	Lupin, Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	217
Start date	2016-04
Completion	2016-09

Conditions

• Mild Persistent Asthma

Interventions

• methacholine chloride
• placebo ProAir HFA
• ProAir HFA
• Lupin albuterol HFA MDI
• placebo Lupin albuterol HFA MDI

Primary outcomes

• Post-dose PC20 Concentration After Receiving Differing Doses of Test, Reference, or Placebo — Post-dose at Visits 2-6 of the study, a total of approximately 4 weeks.
  The primary efficacy endpoint was the postdose PC20 following administration of differing doses of albuterol (or placebo) by inhalation. The 20% reduction in FEV1 was determined relative to the saline stage FEV1 measured before albuterol or placebo administration. Additionally, an analysis of superiority to placebo was performed for the T and R products prior to the BE determination. In this study the ITT and PP populations were identical.

Countries

United States