Loading clinical trials...

BE Study of Albuterol Sulfate Inhalation Aerosol 90 mcg Per Actuation in Patients With Stable Mild Asthma | Clinical Trials | Clareo Health

COMPLETEDPHASE3

BE Study of Albuterol Sulfate Inhalation Aerosol 90 mcg Per Actuation 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.

NCT06154304•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

•1. Subject must have a ≥6-months diagnosis of stable mild asthma based on National Asthma Education and Prevention Program Expert Panel Report 3 (NAEPP EPR3) guidelines (NAEPP EPR3, 2007)
•2. Subject must demonstrate an FEV1 ≥1.5L and ≥80% of predicted based on NHANES III predicted values at the pre-challenge/Pre-saline stage of the first screening MBPC
•a. If a subject's FEV1 at the pre-challenge (baseline/Pre-saline) spirometry is \<80%, but ≥70%, the screening visit may be rescheduled one time (visit must take place within 7 days)
•3. Subject must demonstrate airway responsiveness to methacholine at baseline (pre-albuterol dose) PC20 at ≤8 mg/mL concentration of methacholine (Equivalent to PD20 of ≤513 µg) at the first screening MBPC
•4. Subject must have a BMI of ≥18 kg/m2 and ≤35 kg/m2 at screening.

Exclusion Criteria

•1\. Subject has a fall in FEV1 at the saline stage ≥10% at the screening MBPC. 2. Subject having FEV1 of less than 1.5L at pre-challenge or saline stage of MBPC at any visit. No re-screening/re-scheduling is allowed for such subjects.
•\-

Locations (1)

Velocity CLinical Research

Medford, Oregon, United States

Key Dates

Start Date

December 6, 2023

Primary Completion Date

September 16, 2024

Completion Date

November 29, 2024

Last Updated

July 16, 2025

Enrollment

120

ACTUAL participants

Conditions

Bronchial Asthma

Interventions

Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation)

DRUG

Ventolin HFA 90Mcg/Actuation Inhalation Aerosol_#1

DRUG

Ventolin HFA, 90 Mcg/Inh Inhalation Aerosol_#2

DRUG

Placebo

DRUG

Behavioral Changes Among Asthmatic Children in Sohag Universty Hospital

NCT06624735

Bronchial Asthma

View study

ACTIVE_NOT_RECRUITINGPHASE2

Study of MG-ZG122 Humanized Monoclonal Antibody in Asthma Subjects

NCT07054034

Bronchial Asthma

View study

COMPLETED

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.

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 16, 2025Data 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.

View ClinicalTrials.gov Terms and Conditions

BE Study of Albuterol Sulfate Inhalation Aerosol 90 mcg Per Actuation 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

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

The Role of Genetic Factors in the Development of Bronchial Asthma in the Kazakh Population