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Keep this study
Lead
Cipla Ltd.
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.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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).
Clareo Health | Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma
