Impact of Fixed TRIple Therapy With Beclometasone/Formoterol/Glycopyrronium DPI (Trimbow® in NEXThaler Device) in Chronic Obstructive PulmoNary Disease in rEal-world Settings: Health-related Quality of Life Patient' eXpectations and characterisTics: the TriNEXT Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Chiesi SAS
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Change of quality of life through CAT (COPD assessement tool) over 6 month period
研究概览
简要总结
This is an observational, prospective, multicentric, cohort study conducted in France to evaluate the QoL in COPD patients treated with TRIMBOW NEXThaler 88/5/9 in a routine clinical practice setting. Patients enrolled in this study will be patients diagnosed with a COPD with a ratio of post-bronchodilator (salbutamol 400 μg) forced expiratory volume in 1 s (FEV1) to forced vital capacity (FVC) of less than 0.7 to whom TRIMBOW NEXThaler 88/5/9 has been initiated by an hospital or local pulmonologists in accordance with clinical practice and marketing authorization.
详细描述
The decision of patients to participate in this study must not, in any way, impact upon the standard of care that they are receiving or any benefits to which they are otherwise entitled. The treatment decision must have been taken prior to and independently of the patient's inclusion in the study. All aspects of treatment and clinical management of patients will be at the discretion of the participating pulmonologist (or treating pulmonologist where different) according to local clinical practice and applicable local regulations.
In addition to the data available per clinical practice, the participating pulmonologists will be asked to obtain patient-reported outcome measures (PROMs) data from patients within this study and to invite patients to wear a connected watch to record physical activity and sleep quality (50% of patients (about 250 patients) who first accept to wear the watch will be equipped).
The duration of a patient's participation in this study will be 6 months made of three visits (M0, M3, M6) according to routine clinical practice.
- Visit 1 (M0); inclusion of patient when BDP/FF/GB NEXThaler® 88/5/9 is initiated;
- Visit 2 (M3); 3 months (+/- 30 days) post BDP/FF/GB NEXThaler® 88/5/9 initiation;
- Visit 3 (M6, last visit): 6 months (+/- 30 days) post BDP/FF/GB NEXThaler® 88/5/9 initiation;
The inclusion duration will be 12 to 15 months. The overall duration of the study, including recruitment and follow-up, is expected to be 21 months.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged ≥40 years
- •Diagnosis of COPD with a ratio of post-bronchodilator (salbutamol 400 μg) forced expiratory volume in 1 s (FEV1) to forced vital capacity (FVC) of less than 0.7
- •Physicians' decision to start a first prescription fixed triple therapy with BDP/FF/GB NEXThaler® 88/5/9 in accordance with the marketing authorization
- •COPD Assessment Test (CAT) total score of at least 10 at the day of inclusion
- •Informed consent to participate in the study
排除标准
- •Asthmatic patients
- •Patients with moderate or severe exacerbations within the 4 weeks prior to enrolment
- •Patients treated with fixed triple therapies within 6 months prior inclusion
- •Patients receiving pulmonary rehabilitation within 3 months prior to inclusion or within 6 months after inclusion
- •Concomitant participation in experimental clinical studies/investigations or participation in experimental clinical studies/investigations within 3 months prior to enrolment into the present study
结局指标
主要结局
Change of quality of life through CAT (COPD assessement tool) over 6 month period
时间窗: Month 6
To assess change in QoL using the CAT scale over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device • Primary endpoint is the proportion of patients achieving a ≥2-point reduction in CAT total score (MCID) at M6 compared to baseline.
次要结局
- Mean change Quality of life through VQ11 questionnaire(Month 0, Month 3 and Month 6)
- Proportion of patients achieving a ≥2-point reduction in VQ11 total score(Month 0, Month 3 and Month 6)
- Mean change in Dyspnoea throught "Dyspnea-12 questionnaire"(Month 0, Month 3 and Month 6)
- Proportion of patients achieving a 3-point reduction in "Dyspnea-12" total score(Month 0, Month 3 and Month 6)
- Rate of moderate and severe exacerbations at M0, M3 and M6 through eCRF(Month 0, Month 3 and Month 6)
- Proportion of patients achieving an increase in physical activity throught the a connected device(Month 0, Month 3 and Month 6)
- Mean daily number of steps throught the a connected device(Month 0, Month 3 and Month 6)
- Sleep quality throught the Pittsburgh questionnaire(Month 0, Month 3 and Month 6)
- Sleep quality throught the a connected device(Month 0, Month 3 and Month 6)
- Treatment compliance at M3 and M6 through TAI (test inhaler adherence) questionnary(Month 3 and Month 6)
- Baseline description of sociodemographic data and medical data through eCRF(baseline)
- Treatment tolerance throughout the study through eCRF(up to 24 weeks)