Clinical trial NCT05363202: To Study Generic Fluticasone Propionate Inhalation Aerosol for the Treatment of Bronchial Asthma
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Bronchial Asthma
Lead sponsor: Glenmark Pharmaceuticals Ltd. India
Sponsor class: INDUSTRY
First posted: 2022-05-05
Enrollment: 790
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: - Change from baseline in FEV1 measured in the morning prior to dosing of inhaled medications on the last day of 4-week treatment period
timeFrame: From Baseline to last day of 4-week treatment period
Secondary outcomes:
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Investigational Site 9
state: Gujarat
city: Aurangabad
country: India
facility: Investigational Site 2
state: Maharashtra
city: Nagpur
country: India
facility: Investigational Site 6
state: Maharashtra
city: Nashik
country: India
facility: Investigational Site 16
state: Maharashtra
city: Nashik
country: India
facility: Investigational Site 11
state: Maharashtra
city: Nashik
country: India
facility: Investigational Site 10
state: Maharashtra
city: Pune
country: India
facility: Investigational Site 3
state: Maharashtra
city: Pune
country: India
facility: Investigational Site 1
state: Maharashtra
city: Jaipur
country: India
facility: Investigational Site 4
state: Rajasthan
city: Hyderabad
country: India
facility: Investigational Site 13
state: Telangana
city: Hyderabad
country: India
facility: Investigational Site 5
state: Telangana
Study officials:
affiliation: Glenmark Pharmaceuticals Ltd
name: Ameet Daftary
role: STUDY_DIRECTOR
References: