NCT05363202Unknown3 期
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.
Glenmark Pharmaceuticals Ltd. India11 个研究点 分布在 1 个国家目标入组 790 人开始时间: 2022年4月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 790
- 试验地点
- 11
- 主要终点
- - Change from baseline in FEV1 measured in the morning prior to dosing of inhaled medications on the last day of 4-week treatment period
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Fluticasone propionate inhalation aerosol USP 44 mcg (Glenmark Pharmaceuticals Ltd.)
Experimental
干预措施: Fluticasone propionate Inhalation Aerosol 44 mcg (Drug)
FLOVENT HFA
Active Comparator
干预措施: FLOVENT HFA 44 mcg (Drug)
Placebo of Fluticasone propionate inhalation aerosol 44 mcg
Placebo Comparator
干预措施: Matching Placebo inhaler (Drug)
结局指标
主要结局
- Change from baseline in FEV1 measured in the morning prior to dosing of inhaled medications on the last day of 4-week treatment period
时间窗: From Baseline to last day of 4-week treatment period
次要结局
未报告次要终点
研究者
研究点 (11)
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