Status:
COMPLETED
BE Study of Albuterol Sulfate Inhalation Aerosol 90 mcg Per Actuation in Patients With Stable Mild Asthma
Lead Sponsor:
Cipla Ltd.
Conditions:
Bronchial Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- 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)
- 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)
- 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
- Subject must have a BMI of ≥18 kg/m2 and ≤35 kg/m2 at screening.
Exclusion
- 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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Key Trial Info
Start Date :
December 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06154304
Start Date
December 6 2023
End Date
November 29 2024
Last Update
July 16 2025
Active Locations (1)
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1
Velocity CLinical Research
Medford, Oregon, United States, 97504