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COMPLETEDPHASE3

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

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.

NCT02624505•Cipla Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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).

Locations (1)

Colorado Allergy and Asthma Centers

Denver, Colorado, United States

Key Dates

Start Date

December 1, 2015

Primary Completion Date

October 1, 2016

Completion Date

November 1, 2016

Last Updated

July 25, 2019

Enrollment

110

ACTUAL participants

Conditions

Bronchial Asthma

Interventions

90 mcg Reference Product

DRUG

180 mcg Reference Product

DRUG

90 mcg Test Product

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 25, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

Behavioral Changes Among Asthmatic Children in Sohag Universty Hospital

Study of MG-ZG122 Humanized Monoclonal Antibody in Asthma Subjects

BE Study of Albuterol Sulfate Inhalation Aerosol 90 mcg Per Actuation in Patients With Stable Mild Asthma

the Effect of Use of Vit d and Probiotic as a Supplementaition in the Treatment of Bronchial Asthma in Patient Aged 6 to 50 Year and Its Effect in Decrasing Excerbation.

Echo and Electrocardiographic Findings in Children With Bronchial Asthma At Sohag University Hospital

Assessment of Bronchial Asthma Among Patients Attending Sohag University Hospital