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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Bronchial Asthma

Intervention / Treatment
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* Drug: Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation)
* Drug: Ventolin HFA 90Mcg/Actuation Inhalation Aerosol_#1
* Drug: Ventolin HFA, 90 Mcg/Inh Inhalation Aerosol_#2
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Product<br>One actuation each from four different placebo inhalation aerosols. | Drug: Placebo<br>* Placebo<br>|
| Experimental: Test Product<br>One actuation from the test inhalation aerosol and one actuation each from three different placebo inhalation aerosols | Drug: Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation)<br>* 90 mcg<br>* Other names: Albuterol Test Product;|
| Active Comparator: Reference 90mcg Product<br>One actuation from the reference inhalation aerosol and one actuation each from three different placebo inhalation aerosols. | Drug: Ventolin HFA 90Mcg/Actuation Inhalation Aerosol_#1<br>* 90 mcg<br>* Other names: Albuterol Reference Product;|
| Active Comparator: Reference 180mcg Product<br>One actuation each from two different reference inhalation aerosols and one actuation each from two different placebo inhalation aerosols | Drug: Ventolin HFA, 90 Mcg/Inh Inhalation Aerosol_#2<br>* 180 mcg<br>* Other names: Albuterol Reference Product;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provocative Dose of Methacholine Causing 20 % Fall (PD20) in FEV1(Forced Expiratory Volume in 1 second) | • To compare the bronchoprotective effects of the test product, Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation) [InvaGen Pharmaceuticals Inc., (a subsidiary of Cipla Ltd.) Fall River - MA02720] with the Reference product, Ventolin HFA (Albuterol sulfate inhalation aerosol) 90 mcg per actuation (GlaxoSmithKline, USA), as assessed by methacholine bronchoprovocation challenge (MBPC) testing | 1 day |