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BE Study of Fluticasone Propionate/Salmeterol Inhalation Powder in Asthma Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE3

BE Study of Fluticasone Propionate/Salmeterol Inhalation Powder in Asthma Patients

A Multicenter, Randomized, Parallel-group, Placebo-controlled, 4-week Clinical Endpoint Bioequivalence Study Comparing Fluticasone Propionate/Salmeterol 100/50 µg Inhalation Powder With Advair® Diskus 100/50 µg in Asthma Patients

NCT03394989•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 in adult patients with 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 in adult patients with asthma.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients who have signed informed consent form before initiation of any study related procedure.
•2. Male or female patients who are ≥18 years of age at the time informed consent is obtained.
•3. Documented diagnosis of asthma as defined by the National Asthma Education and Prevention Program (NAEPP) and diagnosed at least 12 weeks prior to screening.
•4. Patients with pre-bronchodilator forced expiratory volume in one second (FEV1) of 40% to 85% (both inclusive) of the predicted normal value at the Screening Visit V2.
•5. Patients who demonstrated an increase of ≥15% of FEV1 within 15 30 minutes following administration of albuterol at Screening Visit V2
•6. Patients who are stable on current asthma treatment for at least 4 weeks prior to Screening Visit V1.
•7. Patients who are able to discontinue their current asthma medications (if any) and any other prohibited medications throughout the study, per the protocol list of prohibited medications during study participation (see Section 6.3.2).
•8. Patients who are able to replace their current short-acting beta 2 agonist (SABA) inhaler with the study provided albuterol inhaler to be used as rescue medicine (as needed) throughout the study. Patients who are able to withhold SABAs for at least 6 hours prior to lung function assessments on study visits.
•9. Patient who are non-smokers or ex-smokers; and have had ≤10 pack years
•10. Patients who have not inhaled tobacco or consumed other tobacco containing products have not inhaled vaping products, drugs of abuse, or inhaled marijuana for at least 12 months prior to screening.
+2 more criteria

Exclusion Criteria

•1. History of life-threatening asthma defined as an asthma episode(s) that required intubation and/or was associated with hypercapnic, respiratory arrest, or hypoxic seizures, asthma related syncopal episode(s) within the past one year.
•2. History of any asthma-related hospitalizations within the past one year.
•3. Any asthma exacerbation requiring emergency room (ER) visits or systemic (including oral) corticosteroids within 2 months prior to signing the consent.
•4. Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia (prolonged QT interval as judged by the investigator). In addition, historical or current evidence of significant hematologic, hepatic neurologic, psychiatric, renal, or other diseases that in the opinion of the investigator, would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbated during the study.
•5. Patients with uncontrolled allergic rhinitis.
•6. Clinical visual evidence of oral candidiasis.
•7. History of any adverse reaction; known hypersensitivity to any sympathomimetic drug
•8. Use of medication(s) with potential to affect the course of asthma or to interact with sympathomimetic amines throughout the study period.
•9. Recent viral or bacterial infection or infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 4 weeks of screening.
•10. Patients, who in the opinion of the investigator, significantly abuse alcohol or drugs will be excluded.
+6 more criteria

Locations (1)

Combined Research Orlando

Orlando, Florida, United States

Key Dates

Start Date

October 17, 2018

Primary Completion Date

December 3, 2019

Completion Date

March 31, 2020

Last Updated

August 13, 2020

Enrollment

1,366

ACTUAL participants

Conditions

Bronchial Asthma

Interventions

Fluticasone propionate/salmeterol 100/50 µg

DRUG

Placebo

OTHER

Advair Diskus 100/50 Dry Powder Inhaler, 60 ACTUAT

DRUG

Behavioral Changes Among Asthmatic Children in Sohag Universty Hospital

NCT06624735

Bronchial Asthma

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ACTIVE_NOT_RECRUITINGPHASE2

Study of MG-ZG122 Humanized Monoclonal Antibody in Asthma Subjects

NCT07054034

Bronchial Asthma

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COMPLETEDPHASE3

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

NCT06154304

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: August 13, 2020Data 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.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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BE Study of Fluticasone Propionate/Salmeterol Inhalation Powder in Asthma Patients

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