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

Primary Purpose

Bronchial Asthma

Status
Recruiting
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Fluticasone propionate Inhalation Aerosol 44 mcg
FLOVENT HFA 44 mcg
Matching Placebo inhaler
Sponsored by
Glenmark Pharmaceuticals Ltd. India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchial Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site 9Recruiting
  • Investigational Site 2Recruiting
  • Investigational Site 6Recruiting
  • Investigational Site 16
  • Investigational Site 11
  • Investigational Site 10
  • Investigational Site 3Recruiting
  • Investigational Site 1Recruiting
  • Investigational Site 4Recruiting
  • Investigational Site 13Recruiting
  • Investigational Site 5Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

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

FLOVENT HFA

Placebo of Fluticasone propionate inhalation aerosol 44 mcg

Arm Description

Outcomes

Primary Outcome Measures

- Change from baseline in FEV1 measured in the morning prior to dosing of inhaled medications on the last day of 4-week treatment period

Secondary Outcome Measures

Full Information

First Posted
May 2, 2022
Last Updated
May 24, 2022
Sponsor
Glenmark Pharmaceuticals Ltd. India
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1. Study Identification

Unique Protocol Identification Number
NCT05363202
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glenmark Pharmaceuticals Ltd. India

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchial Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
790 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fluticasone propionate inhalation aerosol USP 44 mcg (Glenmark Pharmaceuticals Ltd.)
Arm Type
Experimental
Arm Title
FLOVENT HFA
Arm Type
Active Comparator
Arm Title
Placebo of Fluticasone propionate inhalation aerosol 44 mcg
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Fluticasone propionate Inhalation Aerosol 44 mcg
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
FLOVENT HFA 44 mcg
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Matching Placebo inhaler
Intervention Description
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
Primary Outcome Measure Information:
Title
- Change from baseline in FEV1 measured in the morning prior to dosing of inhaled medications on the last day of 4-week treatment period
Time Frame
From Baseline to last day of 4-week treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ameet Daftary, MD
Phone
2016848000
Email
mahesh.deshpande@glenmarkpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ameet Daftary
Organizational Affiliation
Glenmark Pharmaceuticals Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site 9
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
411057
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site 2
City
Aurangabad
State/Province
Maharashtra
ZIP/Postal Code
431002
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site 6
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440009
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site 16
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422002
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site 11
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422005
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site 10
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422007
Country
India
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site 3
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411047
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site 1
City
Pune
State/Province
Maharashtra
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site 4
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302039
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site 13
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500038
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site 5
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500038
Country
India
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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