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

NCT05363202 | Unknown Phase 3 FDA Drug

• 1 other identifier: GLK 2101
• Study Type: interventional
• Target: 790
• Locations: 1 country
• Sites: 11

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.

Conditions

Bronchial Asthma

Outcome Measures

Primary Outcomes (1)

• - 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

Study Arms (3)

Fluticasone propionate inhalation aerosol USP 44 mcg (Glenmark Pharmaceuticals Ltd.)

EXPERIMENTAL

Drug: Fluticasone propionate Inhalation Aerosol 44 mcg

FLOVENT HFA

ACTIVE COMPARATOR

Drug: FLOVENT HFA 44 mcg

Placebo of Fluticasone propionate inhalation aerosol 44 mcg

PLACEBO COMPARATOR

Drug: Matching Placebo inhaler

Interventions

Fluticasone propionate Inhalation Aerosol 44 mcg DRUG

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

Fluticasone propionate inhalation aerosol USP 44 mcg (Glenmark Pharmaceuticals Ltd.)

FLOVENT HFA 44 mcg DRUG

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

Matching Placebo inhaler DRUG

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 of Fluticasone propionate inhalation aerosol 44 mcg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with life-threatening asthma,
• Significant respiratory disease other than asthma
• Evidence or history of clinically significant medical, surgical or psychiatric disease or laboratory abnormalities.
• Known hypersensitivity to any sympathomimetic drug.
• Subjects receiving β2-blockers, anti-arrhythmics, anti-depressants, and/or monoamine oxidase inhibitors within 4 weeks prior to the screening.
• Viral or bacterial, upper or lower respiratory tract infection, or sinus, or middle ear infection within 4 weeks prior to the screening visit
• Subjects who required biologic agents for asthma systemic or oral corticosteroids (for any reason), within the past 6 months prior to screening
• Evidence or history of oral candidiasis, active tuberculosis, hypercorticism, adrenal suppression, or eye problems.
• Female subjects who are pregnant or breast-feeding or planning to be pregnant.
• 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.
• Consumes excessive amounts of alcohol, abuses drugs, or has any condition that would compromise compliance with this protocol.

Sponsors & Collaborators

• Glenmark Pharmaceuticals Ltd. India: lead

Study Sites (11)

Investigational Site 9

Ahmedabad, Gujarat, 411057, India

RECRUITING

Investigational Site 2

Aurangabad, Maharashtra, 431002, India

RECRUITING

Investigational Site 6

Nagpur, Maharashtra, 440009, India

RECRUITING

Investigational Site 16

Nashik, Maharashtra, 422002, India

ACTIVE NOT RECRUITING

Investigational Site 11

Nashik, Maharashtra, 422005, India

ACTIVE NOT RECRUITING

Investigational Site 10

Nashik, Maharashtra, 422007, India

ACTIVE NOT RECRUITING

Investigational Site 3

Pune, Maharashtra, 411047, India

RECRUITING

Investigational Site 1

Pune, Maharashtra, India

RECRUITING

Investigational Site 4

Jaipur, Rajasthan, 302039, India

RECRUITING

Investigational Site 13

Hyderabad, Telangana, 500038, India

RECRUITING

Investigational Site 5

Hyderabad, Telangana, 500038, India

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Ameet Daftary

  Glenmark Pharmaceuticals Ltd

  STUDY DIRECTOR

Central Study Contacts

Ameet Daftary, MD

CONTACT

2016848000; mahesh.deshpande@glenmarkpharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 5, 2022
• Study Start: April 15, 2022
• Primary Completion: May 30, 2024
• Study Completion: August 30, 2024
• Last Updated: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (11)