Status:
UNKNOWN
To Study Generic Fluticasone Propionate Inhalation Aerosol for the Treatment of Bronchial Asthma
Lead Sponsor:
Glenmark Pharmaceuticals Ltd. India
Conditions:
Bronchial Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 US...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2024
Estimated Enrollment :
790 Patients enrolled
Trial Details
Trial ID
NCT05363202
Start Date
April 15 2022
End Date
August 30 2024
Last Update
May 27 2022
Active Locations (11)
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1
Investigational Site 9
Ahmedabad, Gujarat, India, 411057
2
Investigational Site 2
Aurangabad, Maharashtra, India, 431002
3
Investigational Site 6
Nagpur, Maharashtra, India, 440009
4
Investigational Site 16
Nashik, Maharashtra, India, 422002