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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and non-pregnant female subjects (18-65 years of age) Forced Expiratory Volume in 1 second (FEV1) ≥ 80% of predicted. Airway responsiveness to methacholine demonstrated by a pre-albuterol dose (baseline) PC20 ≤ 8 mg/ml. Stable mild asthmatics based on National Asthma Education and Prevention Program (NAEPP) guidelines. Nonsmokers for at least 6 months prior to the study and a maximum smoking history of five pack-years (the equivalent of one pack per day for five years). Written informed consent. Exclusion Criteria: Conditions which could alter airway reactivity to methacholine (e.g., pneumonia, upper respiratory tract infection, viral bronchitis and/or sinobronchitis) within six weeks prior to the screening visit. History of seasonal asthma exacerbations, in which case the patient should be studied outside of the relevant allergen season. History of a clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia. History of cystic fibrosis, bronchiectasis or other respiratory diseases other than Asthma Historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, or other diseases Known intolerance or hypersensitivity or hypersensitivity to any component of the albuterol metered dose inhaler (MDI).

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 two different placebo Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols | Drug: Placebo<br>* Placebo Product<br>|
| Active Comparator: 90 mcg Reference Product<br>Drug : 90 mcg Reference Product One actuation each from the Reference inhalation aerosol and the placebo Reference inhalation aerosol and one actuation each from two different placebo Test inhalation aerosols | Drug: 90 mcg Reference Product<br>* Drug: 90 mcg Reference Product<br>* Other names: Albuterol;|
| Active Comparator: 180 mcg Reference Product<br>Drug: 180 mcg Reference Product One actuation each from two different Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols | Drug: 180 mcg Reference Product<br>* Drug: 180 mcg of Reference Product<br>* Other names: Albuetrol;|
| Experimental: 90 mcg Test Product<br>Drug: 90 mcg Test Product One actuation each from the Test inhalation aerosol and the placebo Test inhalation aerosol and one actuation each from two different placebo Reference inhalation aerosols | Drug: 90 mcg Test Product<br>* Drug: 90 mcg of Test Product<br>* Other names: Albuterol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provocative Concentration of Methacholine Causing 20 % Fall (PC20) in FEV1(Forced Expiratory Volume in 1 second) |  | 1 day |