Bronchial AsthmaPhase 3NCT05363202
To Study Generic Fluticasone Propionate Inhalation Aerosol for the Treatment of Bronchial Asthma
A Phase 3 study testing Fluticasone propionate Inhalation Aerosol 44 mcg and FLOVENT HFA 44 mcg in people with Bronchial Asthma, run by Glenmark Pharmaceuticals Ltd. India at 11 sites in India.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- Fluticasone propionate Inhalation Aerosol 44 mcg and FLOVENT HFA 44 mcg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 790 participants
- Where
- 11 sitesIndia
- Study dates
- 15 Apr 2022to 30 Aug 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
India11 sites, 8 recruiting
- Recruiting
Investigational Site 9
Ahmedabad, Gujarat, 411057
- Recruiting
Investigational Site 2
Chhatrapati Sambhajinagar, Maharashtra, 431002
- Recruiting
Investigational Site 13
Hyderabad, Telangana, 500038
- Recruiting
Investigational Site 5
Hyderabad, Telangana, 500038
- Recruiting
Investigational Site 4
Jaipur, Rajasthan, 302039
- Recruiting
Investigational Site 6
Nagpur, Maharashtra, 440009
- Active, not recruiting
Investigational Site 16
Nashik, Maharashtra, 422002
- Active, not recruiting
Investigational Site 11
Nashik, Maharashtra, 422005
- Active, not recruiting
Investigational Site 10
Nashik, Maharashtra, 422007
- Recruiting
Investigational Site 3
Pune, Maharashtra, 411047
- Recruiting
Investigational Site 1
Pune, Maharashtra
About this study
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.
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
- Being tested
- Fluticasone propionate Inhalation Aerosol 44 mcg, FLOVENT HFA 44 mcg, Matching Placebo inhaler
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone propionate Inhalation Aerosol 44 mcgDrug
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 mcgDrug
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 inhalerDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone propionate inhalation aerosol USP 44 mcg (Glenmark Pharmaceuticals Ltd.) | Experimental | Not described Receives: Drug: Fluticasone propionate Inhalation Aerosol 44 mcg |
| FLOVENT HFA | Active comparator | Not described Receives: Drug: FLOVENT HFA 44 mcg |
| Placebo of Fluticasone propionate inhalation aerosol 44 mcg | Placebo comparator | Not described Receives: Drug: Matching Placebo inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Change from baseline in FEV1 measured in the morning prior to dosing of inhaled medications on the last day of 4-week treatment period
Measured: From Baseline to last day of 4-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start15 Apr 2022
- Primary completion30 May 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 790 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glenmark Pharmaceuticals Ltd. India
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ameet Daftary, Study director, Glenmark Pharmaceuticals Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363202
- Sponsor's protocol ID
- GLK 2101
- Status last verified
- May 2022
- First submitted
- 2 May 2022
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05363202
- Acronym / sponsor ID
- GLK 2101
- Conditions
- Bronchial Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 790 participants (estimated)
- Lead sponsor
- Glenmark Pharmaceuticals Ltd. IndiaIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone propionate Inhalation Aerosol 44 mcgDosage 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 | Drug | Fluticasone propionate inhalation aerosol USP 44 mcg (Glenmark Pharmaceuticals Ltd.) |
| FLOVENT HFA 44 mcgDosage 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 | Drug | FLOVENT HFA |
| Matching Placebo inhalerDosage 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 | Drug | Placebo of Fluticasone propionate inhalation aerosol 44 mcg |
Primary outcome
- 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ameet Daftary study director
Glenmark Pharmaceuticals Ltd
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluticasone propionate Inhalation Aerosol 44 mcg and FLOVENT HFA 44 mcg in people with Bronchial Asthma, run by Glenmark Pharmaceuticals Ltd. India at 11 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ameet Daftary, MD (2016848000, mahesh.deshpande@glenmarkpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: From Baseline to last day of 4-week treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.