Multicenter, Randomized, Double-blind, Double-dummy, National, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Flamboyant 125/12 Association in the Treatment of Adults With Moderate Asthma .
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 134
- 试验地点
- 3
- 主要终点
- Change from baseline in Forced expiratory volume in 1 second (FEV1), obtained through espirometry.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Flamboyant 125/12 association in adults with 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
- Double (Participant, Investigator)
盲法说明
Double-blind and double-dummy
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
- •Participants aged 18 years or more;
- •Diagnosis of uncontrolled moderate asthma;
- •Participants with Forced expiratory volume in 1 second (FEV1) > 60% of predicted;
排除标准
- •Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
- •Known hypersensitivity to the formula components used during the clinical trial;
- •History of alcohol and/or substance abuse within 12 months prior to Screening Visit.
- •Current smoking or smoking history equivalent to "10 pack years"
- •Participants with untreated oral candidiasis;
- •Pulmonary disease history (e.g., chronic obstructive pulmonary disease [COPD], cystic fibrosis, bronchiectasis, tuberculosis);
- •Participants with a history of acute asthma exacerbation, respiratory tract infection or hospitalization for asthma in the last 4 weeks;
- •Known HIV-positive status or active hepatitis B or C virus test result
- •Participants with current evidence or history of uncontrolled coronary artery disease, congestive heart failure, myocardial infarction or cardiac arrhythmia;
- •Participants with current medical history of cancer and/or cancer treatment in the last 5 years;
- •Participants using medications that would have an effect on bronchospasm and / or lung function.
研究组 & 干预措施
FLAMBOYANT 125/12
The study is double-dummy. Thus, the participant must inhale 2 (two) capsules twice a day (12/12h), as follow:
1 Flamboyant 125/12 capsule
1 Budesonide/formoterol 200/6 Placebo capsule.
干预措施: Flamboyant 125/12 (Drug)
FLAMBOYANT 125/12
The study is double-dummy. Thus, the participant must inhale 2 (two) capsules twice a day (12/12h), as follow:
1 Flamboyant 125/12 capsule
1 Budesonide/formoterol 200/6 Placebo capsule.
干预措施: Budesonide/formoterol 200/6 placebo (Other)
Budesonide/formoterol 200/6
The study is double-dummy. Thus, the participant must inhale 2 (two) capsules twice a day (12/12h), as follow:
1 Budesonide/formoterol 200/6 capsule
1 Flamboyant 125/12 Placebo capsule.
干预措施: Budesonide/formoterol 200/6 (Drug)
Budesonide/formoterol 200/6
The study is double-dummy. Thus, the participant must inhale 2 (two) capsules twice a day (12/12h), as follow:
1 Budesonide/formoterol 200/6 capsule
1 Flamboyant 125/12 Placebo capsule.
干预措施: Flamboyant 125/12 Placebo (Other)
结局指标
主要结局
Change from baseline in Forced expiratory volume in 1 second (FEV1), obtained through espirometry.
时间窗: 12 weeks
次要结局
- Incidence and severity of adverse events recorded during the study.(14 weeks)