Pharmacodynamic Bioequivalence Study of Albuterol Sulfate Inhalation Aerosol, 0.09 mg Albuterol Base/ Inhalation

Study Overview
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Brief Summary
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Pharmacodynamic bioequivalence study of Albuterol Sulfate Inhalation Aerosol 0.09 mg

Detailed Description
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To assess the pharmacodynamic bioequivalence of Albuterol Sulfate Inhalation Aerosol 0.09 mg base/ INH [Aurobindo Pharma, USA, Inc] compared to authorized generic drug Albuterol Sulfate HFA Inhalation Aerosol 0.09 mg per actuation [Teva Pharmaceuticals USA, Inc] in stable mild asthma patients, under Methacholine induced bronchoprovocation.

Official Title
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Multi-center, Randomized, Double Blind, Double Dummy, Placebo and Active Controlled, Crossover Pharmacodynamic Bioequivalence Study of Albuterol Sulfate Inhalation Aerosol, 0.09 mg in Stable Mild Asthma Patients

Conditions
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Bronchial Asthma

Intervention / Treatment
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* Other: Methacholine Chloride
* Drug: Albuterol Sulfate HFA 0.09 mg (Reference)
* Drug: Albuterol Sulfate HFA 0.18 mg (Reference)
* Drug: Albuterol Sulfate HFA 0.09 mg (Test)
* Drug: Albuterol Sulfate HFA 0.18 mg (Test)
* 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). Stable mild asthmatics based on National Asthma Education and Prevention Program (NAEPP) guidelines. FEV1 ≥ 80% of predicted. Airway responsiveness to methacholine demonstrated by a pre-albuterol dose (baseline) PC20 ≤ 8 mg/mL or equivalent PD20. Nonsmokers for at least six 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: Evidence of upper or lower respiratory tract infection (e.g., pneumonia, bronchitis, sinusitis) within six weeks prior to the study. History of seasonal asthma exacerbations, in which case the subject should be studied outside of the relevant allergen season. History of cystic fibrosis, bronchiectasis or other respiratory diseases. History of cardiovascular, renal, neurologic, liver or endocrine dysfunction, including ECG with evidence of ischemic heart disease. Treatment in an emergency room or hospitalization for acute asthmatic symptoms or need for daily oral corticosteroids within past three months. Known intolerance or hypersensitivity to any component of the albuterol 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: Zero dose:<br> | Other: Methacholine Chloride<br>* Serial Methacholine dilutions<br>Drug: Placebo<br>* One actuation each from two different placebo Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols.<br>* Other names: Test and Ref Placebos;|
| Active Comparator: Reference 0.09 mg<br> | Other: Methacholine Chloride<br>* Serial Methacholine dilutions<br>Drug: Albuterol Sulfate HFA 0.09 mg (Reference)<br>* 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.<br>* Other names: Reference single dose;|
| Active Comparator: Reference 0.18 mg<br> | Other: Methacholine Chloride<br>* Serial Methacholine dilutions<br>Drug: Albuterol Sulfate HFA 0.18 mg (Reference)<br>* One actuation each from two different Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols.<br>* Other names: Reference double dose;|
| Experimental: Test 0.09 mg<br> | Other: Methacholine Chloride<br>* Serial Methacholine dilutions<br>Drug: Albuterol Sulfate HFA 0.09 mg (Test)<br>* 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.<br>* Other names: Test single dose;|
| Experimental: Test 0.18 mg<br> | Other: Methacholine Chloride<br>* Serial Methacholine dilutions<br>Drug: Albuterol Sulfate HFA 0.18 mg (Test)<br>* One actuation each from two different Test inhalation aerosols and one actuation each from two different placebo Reference inhalation aerosols.<br>* Other names: Test double dose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-dose PD20 | Provocative dose of the methacholine challenge agent required to reduce the forced expiratory volume in one second (FEV1) by 20% following administration of differing doses of albuterol (or placebo) by inhalation. | Over a period of 4 weeks |