NCT05274425进行中（未招募）不适用
A 24-week Prospective, Open-label, Multicenter, Single-arm, Observational Regulatory Post-Marketing Surveillance (rPMS) Study in Real-world Setting (Mandatory by Local HA Regulation) for Enerzair (QVM149 150/50/80 μg o.d. and QVM149 150/50/160 μg o.d. Via Breezhaler)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 683
- 试验地点
- 22
- 主要终点
- Incidence of unexpected adverse events and unexpected serious adverse events
研究概览
简要总结
This surveillance was designed as a prospective, open-label, multicenter, single-arm, non-interventional, observational study to evaluate the safety and effectiveness of Enerzair inhalation capsule for up to 24 weeks under routine clinical practice.
详细描述
The two different doses of Enerzair inhalation capsule via Breezhaler will be prescribed according to the approved label information in Korea, and the investigation for any additional diagnostic or monitoring will be not conducted for this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years of age) with a physician's diagnosis of asthma, who are prescribed Enerzair inhalation capsule (indacaterol acetate/ glycopyrronium bromide/mometasone furoate; 150/50/80, 150/50/160 μg) via Breezhaler, as per the approved label information
- •Patients who participate in the study after signing the consent form for data collection and use (Data Privacy ICF) after receiving a clear explanation of the objectives and nature of the study from the investigator
排除标准
- •Patients who are contraindicated for this medicinal product as described in the Precautions for Use in the label information (package insert) A. Patients with hypersensitivity reaction to this medicinal product or any of its constituents B. Because this medicinal product contains lactose, patients with hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption, etc.
- •Patients with acute asthma symptoms, including acute episodes of bronchospasm, for which a short-acting bronchodilator is required
- •Patients participating in other interventional clinical trials
结局指标
主要结局
Incidence of unexpected adverse events and unexpected serious adverse events
时间窗: 24 weeks
Incidence of unexpected AE and SAE. The term "unexpected" means not listed in local label.
Incidence of adverse events and serious adverse events
时间窗: 24 weeks
Incidence of AE and SAE to be collected
次要结局
- Change from baseline in ACT score(Baseline, week 12)
- Effective rate and ineffective rate by investigator assessment(week 12)
- Baseline characteristics of patients showing adverse drug reactions(24 weeks)
- Baseline characteristics of patients in relation to changes from baseline in trough FEV1(12 weeks)
- Baseline characteristics of patients in relation to the investigator assessment(12 weeks)
- Change from baseline in trough FEV1(Baseline, week 12)
- Baseline characteristics of patients showing adverse events(24 weeks)
- Baseline characteristics of patients in relation to changes from baseline in trough ACT score(12 weeks)
研究者
研究点 (22)
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