To Study Generic Fluticasone Propionate Inhalation Aerosol for the Treatment of Bronchial Asthma

Last updated: May 24, 2022
Sponsor: Glenmark Pharmaceuticals Ltd. India
Overall Status: Active - Recruiting

Phase

3

Condition

Allergies & Asthma

Asthma

Treatment

N/A

Clinical Study ID

NCT05363202
GLK 2101
  • Ages 18-65
  • All Genders

Study Summary

This is a randomized, assessor-blind, placebo controlled, multicenter, clinical endpoint bioequivalence study to compare the efficacy and safety of generic fluticasone propionate inhalation aerosol USP 44 mcg (Glenmark Pharmaceuticals Ltd) to Flovent HFA (fluticasone propionate inhalation aerosol) 44 mcg (GSK group of companies) in treatment of patients with bronchial asthma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult male or female subjects aged between 18 to 65 years of age (both ages inclusive)
  2. Diagnosis of asthma for at least 12 months prior to screening
  3. Pre-bronchodilator FEV1 of more than or equal to 45 % and less than or equal to 85 %.
  4. Subjects should be stable on their chronic asthma treatment regimen for at least 4weeks prior to screening
  5. Currently non-smoking;
  6. More than or equal to 15 % reversibility of FEV1 within 30 min following 360 mcg ofAlbuterol/salbutamol inhalation (pMDI) at screening
  7. Ability to discontinue their asthma controller medication safely
  8. Ability to replace short-acting β agonists (SABAs) ongoing at screening withAlbuterol/salbutamol inhaler.
  9. Women of childbearing potential must be willing to consistently use an appropriatemethod of contraception.
  10. Willingness to give their written informed consent to participate in the study.
  11. Is willing to comply with all aspects of the protocol.
  12. Ability to follow training given for study related procedures and assessments in theopinion of the Investigator.

Exclusion

Exclusion Criteria:

  1. Patients with life-threatening asthma,
  2. Significant respiratory disease other than asthma
  3. Evidence or history of clinically significant medical, surgical or psychiatric diseaseor laboratory abnormalities.
  4. Known hypersensitivity to any sympathomimetic drug.
  5. Subjects receiving β2-blockers, anti-arrhythmics, anti-depressants, and/or monoamineoxidase inhibitors within 4 weeks prior to the screening.
  6. Viral or bacterial, upper or lower respiratory tract infection, or sinus, or middleear infection within 4 weeks prior to the screening visit
  7. Subjects who required biologic agents for asthma systemic or oral corticosteroids (forany reason), within the past 6 months prior to screening
  8. Evidence or history of oral candidiasis, active tuberculosis, hypercorticism, adrenalsuppression, or eye problems.
  9. Female subjects who are pregnant or breast-feeding or planning to be pregnant.
  10. Currently enrolled in another clinical study or used any investigational product (study drug), study drug, or device within 30 days or 5 elimination half-lives,whichever is longer, preceding informed consent.
  11. Consumes excessive amounts of alcohol, abuses drugs, or has any condition that wouldcompromise compliance with this protocol.

Study Design

Total Participants: 790
Study Start date:
April 15, 2022
Estimated Completion Date:
August 30, 2024

Connect with a study center

  • Investigational Site 9

    Ahmedabad, Gujarat 411057
    India

    Active - Recruiting

  • Investigational Site 2

    Aurangabad, Maharashtra 431002
    India

    Active - Recruiting

  • Investigational Site 6

    Nagpur, Maharashtra 440009
    India

    Active - Recruiting

  • Investigational Site 10

    Nashik, Maharashtra 422007
    India

    Site Not Available

  • Investigational Site 11

    Nashik, Maharashtra 422005
    India

    Site Not Available

  • Investigational Site 16

    Nashik, Maharashtra 422002
    India

    Site Not Available

  • Investigational Site 1

    Pune, Maharashtra
    India

    Active - Recruiting

  • Investigational Site 3

    Pune, Maharashtra 411047
    India

    Active - Recruiting

  • Investigational Site 4

    Jaipur, Rajasthan 302039
    India

    Active - Recruiting

  • Investigational Site 13

    Hyderabad, Telangana 500038
    India

    Active - Recruiting

  • Investigational Site 5

    Hyderabad, Telangana 500038
    India

    Active - Recruiting

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