A Real-World Study Evaluates the Clinical Characteristics and Effectiveness of COPD Patients Treated With the Triple Combination Beclometasone Diproprionate/Formoterol Fumarate/Glycopyrronium Bromide (BDP/FF/GB) in a Single Pressurised Metered Dose Inhaler (Trimbow® pMDI) in Brazil
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 396
- 试验地点
- 1
- 主要终点
- Assessment of the CAT (COPD assessment test) total score vs baseline at month 6
研究概览
简要总结
This multicenter, retrospective-prospective, cohort study aims to evaluate the effectiveness and safety of Extra-fine Beclometasone Diproprionate/Formoterol Fumarate/Glycopyrronium Bromide (EF-BDP/FF/GB) therapy in adults with severe or very severe COPD in Brazil. Around 400 patients will be enrolled across approximately 15 sites. Eligible patients must have started treatment on the day of enrollment or up to three months before enrollment. Data will be collected both retrospectively and prospectively, with baseline information covering up to 12 months before treatment initiation. All assessments will occur during routine medical visits, with follow-up expected at approximately 3 ± 1 month and 6 months ± 2 months. The medication Trimbow® will not be provided as part of the study and must be prescribed and used according to the institution's standard clinical practice, regardless of participation in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female patients ≥ 40 years old at the time of BDP/FF/GB initiation
- •Patients with documented diagnosis of severe or very severe COPD prior to BDP/FF/GB initiation
- •Patients with CAT total score ≥ 10 at baseline (at the time of BDP/FF/GB initiation or within the 12 months before treatment initiation*) *If no CAT total score is available on BDP/FF/GB initiation date)
- •Patients with at least ≥ 1 COPD exacerbation within the previous 12 months before enrollment.
- •Patients who started treatment with BDP/FF/GB within 3-months before signing the Informed Consent Form (ICF), or on the date of the ICF signature according to Trimbow® Summary of Product Characteristics (SmPC)
- •Patients who are willing and able to give their written consent to participate in the study
排除标准
- •- Patient known to be participating in any interventional study during the study period and in the 3 months prior to BDP/FF/GB initiation.
研究组 & 干预措施
Trimbow
Adult patients with COPD treated with triple combination Beclometasone Diproprionate/Formoterol Fumarate/Glycopyrronium Bromide (BDP/FF/GB) as per local clinical practice
干预措施: BDP/FF/GB (100ug/6ug/12.5ug) (Drug)
结局指标
主要结局
Assessment of the CAT (COPD assessment test) total score vs baseline at month 6
时间窗: Baseline and 6 months (±2 months)
The test has a score of 0 (minimum) - 40 (maximum); a lower score means a better outcome, and a higher score means a worse outcome.
次要结局
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](6 months (±2))
- Assessment of the CAT (COPD assessment test) total score vs baseline at month 3(Baseline and 3 months (±1))
- Change of Forced Expiratory Volume in one second assessed via spirometry(Baseline and 6 months (±2))
- Change of Forced Vital Capacity assessed via spirometry(Baseline and 6 months (±2))
- Change of FEV1/FVC ratio assessed via spirometry(Baseline and 6 months (±2))
- Change of Forced Expiratory Flow at 25-75% of forced vital capacity via spirometry(Baseline and 6 months (±2))
- Safety Measure(6 months (±2))
- Descriptive statistics(Baseline and 6 months (±2))