Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma

Phase 3

Completed

• Conditions: Bronchial Asthma
• Interventions: Drug: Placebo; Drug: 180 mcg Reference Product; Drug: 90 mcg Reference Product; Drug: 90 mcg Test Product

• Registration Number: NCT02624505
• Lead Sponsor: Cipla Ltd.

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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-04
• Study First Submitted QC: 2015-12-04
• Study First Posted: 2015-12-08
• Primary Completion: 2016-10
• Study Completion: 2016-11
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-23
• Last Update Posted: 2019-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo Product	Placebo	One actuation each from two different placebo Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols
180 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
90 mcg Reference Product	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
90 mcg Test 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

Primary Outcome Measures

Name	Time	Method
Provocative Concentration of Methacholine Causing 20 % Fall (PC20) in FEV1(Forced Expiratory Volume in 1 second)	1 day

Trial Locations

Locations (1)

Colorado Allergy and Asthma Centers; 🇺🇸 Denver, Colorado, United States