NCT05217810招募中不适用
A 24-week Prospective, Open-label, Multicenter, Single-arm Regulatory Post-Marketing Surveillance (rPMS) Study in Real-world Setting (Mandatory by Local HA Regulation) for Atectura® (QMF149 150/80 μg o.d., QMF149 150/160 μg o.d. and QMF149 150/320 μg o.d. Via Breezhaler)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 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 Atectura inhalation capsule for up to 24 weeks under routine clinical practice.
详细描述
The three different doses of Atectura 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
- 12 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescent (≥12 years of age) and adult patients with a physician's diagnosis of asthma, who are prescribed Atectura inhalation capsule (indacaterol acetate/mometasone furoate; 150/80, 150/160, 150/320 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 (For patients under the age of 18, consent and signature of a legal representative is required)
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 will be collected. 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 will be collected
次要结局
- Baseline characteristics of patients in relation to the investigator assessment(12 weeks)
- change from baseline in trough FEV1(Baseline, week 12)
- Effective rate and ineffective rate by investigator assessment(week 12)
- change from baseline in ACT score(Baseline, week 12)
- Baseline characteristics of patients showing adverse events/adverse drug reactions(24 weeks)
- Baseline characteristics of patient in relation to changes from baseline through FEV1 and ACT score(12 weeks)
研究者
研究点 (1)
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