Clincosm LogoSign in Get a demo

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

Sponsor
Cipla Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06154304
Collaborator
(none)
120
Enrollment
1
Location
4
Arms
9.4
Anticipated Duration (Months)
12.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: 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
 Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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.
Anticipated Study Start Date :
Dec 11, 2023
Anticipated Primary Completion Date :
Aug 12, 2024
Anticipated Study Completion Date :
Sep 23, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo Product

One actuation each from four different placebo inhalation aerosols.

Drug: Placebo
Placebo
Experimental: Test Product

One actuation from the test inhalation aerosol and one actuation each from three different placebo inhalation aerosols

Drug: Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation)
90 mcg
Other Names:
  • Albuterol Test Product

    		•
    Active Comparator: Reference 90mcg Product

    One actuation from the reference inhalation aerosol and one actuation each from three different placebo inhalation aerosols.

    Drug: Ventolin HFA 90Mcg/Actuation Inhalation Aerosol_#1
    90 mcg
    Other Names:
  • Albuterol Reference Product

    		•
    Active Comparator: Reference 180mcg Product

    One actuation each from two different reference inhalation aerosols and one actuation each from two different placebo inhalation aerosols

    Drug: Ventolin HFA, 90 Mcg/Inh Inhalation Aerosol_#2
    180 mcg
    Other Names:
  • Albuterol Reference Product

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Provocative Dose of Methacholine Causing 20 % Fall (PD20) in FEV1(Forced Expiratory Volume in 1 second) [1 day]

      • To compare the bronchoprotective effects of the test product, Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation) [InvaGen Pharmaceuticals Inc., (a subsidiary of Cipla Ltd.) Fall River - MA02720] with the Reference product, Ventolin HFA (Albuterol sulfate inhalation aerosol) 90 mcg per actuation (GlaxoSmithKline, USA), as assessed by methacholine bronchoprovocation challenge (MBPC) testing

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. 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)

    1. 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

    2. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Velocity CLinical Research Medford Oregon United States 97504

    Sponsors and Collaborators

    • Cipla Ltd.

    Investigators

    • Principal Investigator: Sarah Smiley, Velocity Clinical Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cipla Ltd.
    ClinicalTrials.gov Identifier:
    NCT06154304
    Other Study ID Numbers:
    • CRD/58
    First Posted:
    Dec 4, 2023
    Last Update Posted:
    Dec 4, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Asthma
    Albuterol

    Study Results

    No Results Posted as of Dec 4, 2023