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.
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Bronchial Asthma
- Sponsor
- Cipla Ltd.
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Provocative Concentration of Methacholine Causing 20 % Fall (PC20) in FEV1(Forced Expiratory Volume in 1 second)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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 with stable mild asthma.
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 challenge testing) in adult patients with stable mild asthma.
Investigators
Eligibility Criteria
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).
Arms & Interventions
Placebo Product
One actuation each from two different placebo Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols
Intervention: Placebo
90 mcg Reference Product
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
Intervention: 90 mcg Reference Product
180 mcg Reference Product
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
Intervention: 180 mcg Reference Product
90 mcg Test Product
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
Intervention: 90 mcg Test Product
Outcomes
Primary Outcomes
Provocative Concentration of Methacholine Causing 20 % Fall (PC20) in FEV1(Forced Expiratory Volume in 1 second)
Time Frame: 1 day