NCT03963167已完成不适用
The Impact on the Health Status and Adherence in a Real-life Setting of Italian Patients With Chronic Obstructive Pulmonary Disease in Treatment With Trimbow® pMDI b.i.d.: a 12-month Prospective Observational Study
Chiesi Italia1 个研究点 分布在 1 个国家目标入组 661 人开始时间: 2019年8月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 661
- 试验地点
- 1
- 主要终点
- Change in COPD Assessment Test (CAT) score
研究概览
简要总结
The mean objectives are to evaluate the impact of BDP/FF/G fixed combination on health-status and adherence
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent to participate in the study;
- •Adult patients of either sex aged ≥ 40 years;
- •Patients with diagnosis of moderate to very severe COPD according to Gold Initiative for Chronic Obstructive Lung Disease (GOLD) updated 2019 (GOLD Stage 2-4);
- •COPD assessment test (CAT) score ≥ 10 at initiation of BDP/FF/G fixed combination;
- •History of >1 moderate or severe COPD exacerbation during the previous year.
- •Patients in treatment with BDP/FF/G as per local clinical practice and according to Trimbow® Summary of Product Characteristics (SmPC).
排除标准
- •According on Investigator's judgement, patients unable to comply with the requirements of the study (e.g. inability to attend all the planned study visits according to the time limits included) or patients with poorly controlled concomitant severe diseases or conditions that could interfere with the study participation;
- •Participation in an interventional clinical trial within 30 days prior to enrolment into the present study.
研究组 & 干预措施
Patient in treatment with BDP/FF/G fixed combination
干预措施: BDP/FF/G fixed combination (Drug)
结局指标
主要结局
Change in COPD Assessment Test (CAT) score
时间窗: 12 months
CAT consists of 8 items scored on a scale of 1 to 5, with a total score range of 0-40. A higher score denotes a more severe impact of COPD on the patient's life.
次要结局
- Mean forced expiratory flow between 25% and 75% of the FVC (FEF25-75)(Baseline, 6 and 12 months)
- Change in COPD Assessment Test (CAT) score(6 months)
- Change in EuroQoL score(6 and 12 months)
- Change in 12-item Test of Adherence to Inhalers (TAI-12) score(6 and 12 months)
- Forced Vital Capacity (FVC, L)(Baseline, 6 and 12 months)
- Use of rescue medication(Baseline, 6 and 12 months)
- Change in COPD and Asthma Sleep Impact Scale (CASIS) score(6 and 12 months)
- Change of an 8-item questionnaire on satisfaction and usability of the device score from baseline (Visit 1)(6 and 12 months)
- Forced Expiratory Volume in the first second (FEV1, L)(Baseline, 6 and 12 months)
- Ratio FEV1/FVC(Baseline, 6 and 12 months)
- Exacerbations(Baseline, 6 and 12 months)
- Adverse events(Baseline, 6 and 12 months)
- Economic resources consumption(Baseline, 6 and 12 months)
研究者
研究点 (1)
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