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

• Status: Not yet recruiting
• Trial end date: 2024-09-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cipla Ltd.
• Treatments: Albuterol

Criteria

Inclusion Criteria:

1. Subject must have a ≥6-months diagnosis of stable mild asthma based on National Asthma Education and Prevention Program Expert Panel Report 3 (NAEPP EPR3) guidelines (NAEPP EPR3, 2007)

2. Subject must demonstrate an FEV1 ≥1.5L and ≥80% of predicted based on NHANES III predicted values at the pre-challenge/Pre-saline stage of the first screening MBPC

a. If a subject's FEV1 at the pre-challenge (baseline/Pre-saline) spirometry is <80%, but ≥70%, the screening visit may be rescheduled one time (visit must take place within 7 days)

3. Subject must demonstrate airway responsiveness to methacholine at baseline (pre-albuterol dose) PC20 at ≤8 mg/mL concentration of methacholine (Equivalent to PD20 of ≤513 µg) at the first screening MBPC

4. Subject must have a BMI of ≥18 kg/m2 and ≤35 kg/m2 at screening.

Exclusion Criteria:

1. Subject has a fall in FEV1 at the saline stage ≥10% at the screening MBPC. 2. Subject having FEV1 of less than 1.5L at pre-challenge or saline stage of MBPC at any visit. No re-screening/re-scheduling is allowed for such subjects.

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