Clincosm LogoSign in Get a demo

Pharmacodynamic Bioequivalence Study of Albuterol Sulfate Inhalation Aerosol, 0.09 mg Albuterol Base/ Inhalation

Sponsor
Aurobindo Pharma Ltd (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT05292976
Collaborator
(none)
0
Enrollment
1
Location
5
Arms
8
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Pharmacodynamic bioequivalence study of Albuterol Sulfate Inhalation Aerosol 0.09 mg

Condition or Disease Intervention/Treatment Phase
  • Other: Methacholine Chloride
  • Drug: Albuterol Sulfate HFA 0.09 mg (Reference)
  • Drug: Albuterol Sulfate HFA 0.18 mg (Reference)
  • Drug: Albuterol Sulfate HFA 0.09 mg (Test)
  • Drug: Albuterol Sulfate HFA 0.18 mg (Test)
  • Drug: Placebo
 Phase 3

Detailed Description

To assess the pharmacodynamic bioequivalence of Albuterol Sulfate Inhalation Aerosol 0.09 mg base/ INH [Aurobindo Pharma, USA, Inc] compared to authorized generic drug Albuterol Sulfate HFA Inhalation Aerosol 0.09 mg per actuation [Teva Pharmaceuticals USA, Inc] in stable mild asthma patients, under Methacholine induced bronchoprovocation.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Double Dummy
Primary Purpose:
Treatment
Official Title:
Multi-center, Randomized, Double Blind, Double Dummy, Placebo and Active Controlled, Crossover Pharmacodynamic Bioequivalence Study of Albuterol Sulfate Inhalation Aerosol, 0.09 mg in Stable Mild Asthma Patients
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Zero dose:

Other: Methacholine Chloride
Serial Methacholine dilutions

Drug: Placebo
One actuation each from two different placebo Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols.
Other Names:
  • Test and Ref Placebos

    		•
    Active Comparator: Reference 0.09 mg

    Other: Methacholine Chloride
    Serial Methacholine dilutions

    Drug: Albuterol Sulfate HFA 0.09 mg (Reference)
    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.
    Other Names:
  • Reference single dose

    		•
    Active Comparator: Reference 0.18 mg

    Other: Methacholine Chloride
    Serial Methacholine dilutions

    Drug: Albuterol Sulfate HFA 0.18 mg (Reference)
    One actuation each from two different Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols.
    Other Names:
  • Reference double dose

    		•
    Experimental: Test 0.09 mg

    Other: Methacholine Chloride
    Serial Methacholine dilutions

    Drug: Albuterol Sulfate HFA 0.09 mg (Test)
    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.
    Other Names:
  • Test single dose

    		•
    Experimental: Test 0.18 mg

    Other: Methacholine Chloride
    Serial Methacholine dilutions

    Drug: Albuterol Sulfate HFA 0.18 mg (Test)
    One actuation each from two different Test inhalation aerosols and one actuation each from two different placebo Reference inhalation aerosols.
    Other Names:
  • Test double dose

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Post-dose PD20 [Over a period of 4 weeks]

      Provocative dose of the methacholine challenge agent required to reduce the forced expiratory volume in one second (FEV1) by 20% following administration of differing doses of albuterol (or placebo) by inhalation.

    Eligibility Criteria

    Criteria

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

    1. Male and non-pregnant female subjects (18-65 years of age).

    2. Stable mild asthmatics based on National Asthma Education and Prevention Program (NAEPP) guidelines.

    3. FEV1 ≥ 80% of predicted.

    4. Airway responsiveness to methacholine demonstrated by a pre-albuterol dose (baseline) PC20 ≤ 8 mg/mL or equivalent PD20.

    5. Nonsmokers for at least six months prior to the study and a maximum smoking history of five pack-years (the equivalent of one pack per day for five years).

    6. Written informed consent.

    Exclusion Criteria:

    1. Evidence of upper or lower respiratory tract infection (e.g., pneumonia, bronchitis, sinusitis) within six weeks prior to the study.

    2. History of seasonal asthma exacerbations, in which case the subject should be studied outside of the relevant allergen season.

    3. History of cystic fibrosis, bronchiectasis or other respiratory diseases.

    4. History of cardiovascular, renal, neurologic, liver or endocrine dysfunction, including ECG with evidence of ischemic heart disease.

    5. Treatment in an emergency room or hospitalization for acute asthmatic symptoms or need for daily oral corticosteroids within past three months.

    6. Known intolerance or hypersensitivity to any component of the albuterol MDI

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational site #1 San Jose California United States 95117

    Sponsors and Collaborators

    • Aurobindo Pharma Ltd

    Investigators

    • Study Director: Joseph Marialouis, MD, Aurobindo Pharma Ltd

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aurobindo Pharma Ltd
    ClinicalTrials.gov Identifier:
    NCT05292976
    Other Study ID Numbers:
    • CR206-19
    First Posted:
    Mar 23, 2022
    Last Update Posted:
    May 20, 2022
    Last Verified:
    May 1, 2022
    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
    Methacholine Chloride

    Study Results

    No Results Posted as of May 20, 2022