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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Bronchial Asthma
• Intervention / Treatment: Drug: Fluticasone propionate Inhalation Aerosol 44 mcg; Drug: FLOVENT HFA 44 mcg; Drug: Matching Placebo inhaler

• Study Type: Interventional
• Enrollment (Anticipated): 790
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ameet Daftary, MD; Phone Number: 2016848000; Email: mahesh.deshpande@glenmarkpharma.com

Study Locations

• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 411057
      • Recruiting
      • Investigational Site 9
  • Maharashtra
    • Aurangabad, Maharashtra, India, 431002
      • Recruiting
      • Investigational Site 2
    • Nagpur, Maharashtra, India, 440009
      • Recruiting
      • Investigational Site 6
    • Nashik, Maharashtra, India, 422002
      • Active, not recruiting
      • Investigational site 16
    • Nashik, Maharashtra, India, 422005
      • Active, not recruiting
      • Investigational site 11
    • Nashik, Maharashtra, India, 422007
      • Active, not recruiting
      • Investigational site 10
    • Pune, Maharashtra, India, 411047
      • Recruiting
      • Investigational Site 3
    • Pune, Maharashtra, India
      • Recruiting
      • Investigational Site 1
  • Rajasthan
    • Jaipur, Rajasthan, India, 302039
      • Recruiting
      • Investigational Site 4
  • Telangana
    • Hyderabad, Telangana, India, 500038
      • Recruiting
      • Investigational site 13
    • Hyderabad, Telangana, India, 500038
      • Recruiting
      • Investigational Site 5

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 4 weeks prior to screening
5. Currently non-smoking;
6. More than or equal to 15 % reversibility of FEV1 within 30 min following 360 mcg of Albuterol/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 with Albuterol/salbutamol inhaler.
9. Women of childbearing potential must be willing to consistently use an appropriate method 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 the opinion of the Investigator.

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 disease or laboratory abnormalities.
4. Known hypersensitivity to any sympathomimetic drug.
5. Subjects receiving β2-blockers, anti-arrhythmics, anti-depressants, and/or monoamine oxidase inhibitors within 4 weeks prior to the screening.
6. Viral or bacterial, upper or lower respiratory tract infection, or sinus, or middle ear infection within 4 weeks prior to the screening visit
7. Subjects who required biologic agents for asthma systemic or oral corticosteroids (for any reason), within the past 6 months prior to screening
8. Evidence or history of oral candidiasis, active tuberculosis, hypercorticism, adrenal suppression, 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 would compromise compliance with this protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluticasone propionate inhalation aerosol USP 44 mcg (Glenmark Pharmaceuticals Ltd.)	Drug: Fluticasone propionate Inhalation Aerosol 44 mcg; Dosage Form: Metered dose Inhalation Aerosol Dosage Frequency 44 mcg (two inhalations; twice daily (i.e. morning & evening approximately. 12 h apart, Mode of Administration: Oral inhalation
Active Comparator: FLOVENT HFA	Drug: FLOVENT HFA 44 mcg; Dosage Form: Metered dose Inhalation Aerosol Dosage Frequency 44 mcg (two inhalations; twice daily (i.e. morning & evening approximately. 12 h apart, Mode of Administration: Oral inhalation
Placebo Comparator: Placebo of Fluticasone propionate inhalation aerosol 44 mcg	Drug: Matching Placebo inhaler; Dosage Form: Metered dose Inhalation Aerosol Dosage Frequency 44 mcg (two inhalations; twice daily (i.e. morning & evening approximately. 12 h apart, Mode of Administration: Oral inhalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
- Change from baseline in FEV1 measured in the morning prior to dosing of inhaled medications on the last day of 4-week treatment period	From Baseline to last day of 4-week treatment period

Collaborators and Investigators

• Sponsor: Glenmark Pharmaceuticals Ltd. India
• Investigators: Study Director: Ameet Daftary, Glenmark Pharmaceuticals Ltd

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2022
• Primary Completion (Anticipated): May 30, 2024
• Study Completion (Anticipated): August 30, 2024

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Fluticasone; Xhance
• Other Study ID Numbers: GLK 2101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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.: Yes