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

Bronchial Asthma Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05363202
• Other study ID #: GLK 2101
• Status: Recruiting
• Phase: Phase 3
• Start date: April 15, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: May 2022
• Source: Glenmark Pharmaceuticals Ltd. India
• Contact: Ameet Daftary, MD
• Phone: 2016848000
• Email: mahesh.deshpande[@]glenmarkpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 790
• Est. completion date: August 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ß 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 ß2-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.

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
India	Investigational Site 9	Ahmedabad	Gujarat
India	Investigational Site 2	Aurangabad	Maharashtra
India	Investigational Site 13	Hyderabad	Telangana
India	Investigational Site 5	Hyderabad	Telangana
India	Investigational Site 4	Jaipur	Rajasthan
India	Investigational Site 6	Nagpur	Maharashtra
India	Investigational Site 10	Nashik	Maharashtra
India	Investigational Site 11	Nashik	Maharashtra
India	Investigational Site 16	Nashik	Maharashtra
India	Investigational Site 1	Pune	Maharashtra
India	Investigational Site 3	Pune	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Glenmark Pharmaceuticals Ltd. India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- 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