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

May 24, 2022 updated by: Glenmark Pharmaceuticals Ltd. India

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
790

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: From Baseline to last day of 4-week treatment period
From Baseline to last day of 4-week treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Glenmark Pharmaceuticals Ltd. India

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ameet Daftary, Glenmark Pharmaceuticals Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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