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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Data collection will be considered complete for a participating patient if data available at 6 have been recorded in the CRF and associated PROs completed. Patients will be followed until the end of the study period (M6) even if TRIMBOW NEXThaler 88/5/9 is discontinued.

Official Title
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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

Conditions
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COPD

Intervention / Treatment
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* Drug: Beclometasone/Formoterol/Glycopyrronium 88 µg/5 µg/9 µg DPI (Trimbow® 88 µg/5 µg/9 µg in NEXThaler device)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Beclometasone/Formoterol/Glycopyrronium 88 µg/5 µg/9 µg DPI (Trimbow® 88 µg/5 µg/9 µg in NEXThaler device)|observational, prospective, multicentric, international, cohort study|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of quality of life through CAT (COPD assessement tool) over 6 month period | 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. | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change Quality of life through VQ11 questionnaire | To assess change in QoL using the VQ11 scale over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device • Endpoint is mean VQ11 total score and sub scores described at baseline, M3 and M6 | Month 0, Month 3 and Month 6 | 
| Proportion of patients achieving a ≥2-point reduction in VQ11 total score | To assess change in QoL using the VQ11 scale over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device • Endpoint is the proportion of patients achieving a ≥2-point reduction in VQ11 total score (MCID) at M3 and M6 compared to baseline. | Month 0, Month 3 and Month 6 | 
| Mean change in Dyspnoea throught Dyspnea-12 questionnaire | To assess changes in dyspnoea using the Dyspnea-12 over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device • Endpoint is D-12 total score and sub scores described at baseline, M3 and M6 | Month 0, Month 3 and Month 6 | 
| Proportion of patients achieving a 3-point reduction in Dyspnea-12 total score | To assess changes in dyspnoea using the Dyspnea-12 over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device • Endpoint is the proportion of patients achieving a 3-point reduction in D-12 total score (MCID) at M3 and M6 compared to baseline. | Month 0, Month 3 and Month 6 | 
| Rate of moderate and severe exacerbations at M0, M3 and M6 through eCRF | To describe the occurrence of moderate to severe exacerbations over a 6- month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device Endpoint is the proportion of patients with at least a moderate or severe exacerbation (overall and in each category), at baseline (in the previous 12 months), M3 and M6 | Month 0, Month 3 and Month 6 | 
| Proportion of patients achieving an increase in physical activity throught the a connected device | To assess changes in physical activity using a connected watch over a 6-month • Endpoint is the proportion of patients achieving an increase in physical activity (≥ 10%-increase in the mean daily number of step) at M3 and M6 compared to baseline. Baseline physical activity (M0) will be defined as the mean of data collected during the first 7 days of connected device wearing watch over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device | Month 0, Month 3 and Month 6 | 
| Mean daily number of steps throught the a connected device | To assess changes in physical activity using a connected watch over a 6-month • Endpoints are the mean daily number of steps and the mean of number of steps during 7 days at M0, M3 and M6 Baseline physical activity (M0) will be defined as the mean of data collected during the first 7 days of connected device wearing watch over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device | Month 0, Month 3 and Month 6 | 
| Sleep quality throught the Pittsburgh questionnaire | • Endpoints are the Pittsburgh questionnaire at M0, M3 and M6 Baseline physical activity (M0) will be defined as the mean of data collected during the first 7 days of connected device wearing. | Month 0, Month 3 and Month 6 | 
| Sleep quality throught the a connected device | To assess changes in sleep quality using a connected device • Endpoints are the mean daily sleep time, the mean of sleep time and the mean daily number of awakenings during 7 days at M0, M3 and M6 Baseline sleep quality (M0) will be defined as the mean of data collected during the first 7 days of connected device wearing. | Month 0, Month 3 and Month 6 | 
| Treatment compliance at M3 and M6 through TAI (test inhaler adherence) questionnary | To assess treatment compliance with BDP/FF/G (88/5/9) in NEXThaler® device • Endpoint is the description of treatment compliance global score at M3 and M6 for COPD using TAI | Month 3 and Month 6 | 
| Baseline description of sociodemographic data and medical data through eCRF | to describe COPD patient, disease and treatment characteristics at initiation of BDP/FF/G (88/5/9) in NEXThaler® device Endpoints are description of sociodemographic (age, sex, weight, height, education level, occupation), medical data (risk factors exposure including tobacco, disease history) and lung function data (FEV1, FVC, RV, TLC) at baseline Endpoints are description of comorbidities and associated treatment throughout the study at baseline Endpoints are description of previous COPD-related treatment at baseline through eCRF | baseline | 
| Treatment tolerance throughout the study through eCRF | To assess treatment tolerance in COPD patients treated with with BDP/FF/G (88/5/9) in NEXThaler® device To assess patient satisfaction with treatment in COPD patients treated with BDP/FF/GB NEXThaler® 88/5/9 | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital, QOL, PROMS, PRO, respiratory diseases, Chronic obstructive pulmonary disease (COPD), Adult, observational, connected device, quality of life