Clinical trial NCT05948891: 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
Official title: 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 type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COPD
Keywords: Digital
QOL
PROMS
PRO
respiratory diseases
Chronic obstructive pulmonary disease (COPD)
Adult
observational
connected device
quality of life
Lead sponsor: Chiesi SAS
Sponsor class: INDUSTRY
Collaborators: name: Kappa Santé
First posted: 2023-07-17
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients participating in this non-interventional real-world evidence study will be COPD patients for whom it has been decided to initiate BDP/FF/G (88/5/9) in NEXThaler® device by a physician in accordance with clinical practice

All eligible patients should be offered enrolment for data collection within the study. Participating sites will be encouraged to propose the study to all patients satisfying eligibility criteria, in a consecutive manner, when patients come for their regular consultation, in order to minimize bias in patient selection. In any case, the treatment decision must have been taken by the investigator prior to, and independently of the patient's inclusion into the study, following standard clinical practice and regulations.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of quality of life through CAT (COPD assessement tool) over 6 month period
timeFrame: Month 6
Secondary outcomes:
measure: Mean change Quality of life through VQ11 questionnaire
timeFrame: Month 0, Month 3 and Month 6
measure: Proportion of patients achieving a ≥2-point reduction in VQ11 total score
timeFrame: Month 0, Month 3 and Month 6
measure: Mean change in Dyspnoea throught "Dyspnea-12 questionnaire"
timeFrame: Month 0, Month 3 and Month 6
measure: Proportion of patients achieving a 3-point reduction in "Dyspnea-12" total score
timeFrame: Month 0, Month 3 and Month 6
measure: Rate of moderate and severe exacerbations at M0, M3 and M6 through eCRF
timeFrame: Month 0, Month 3 and Month 6
measure: Proportion of patients achieving an increase in physical activity throught the a connected device
timeFrame: Month 0, Month 3 and Month 6
measure: Mean daily number of steps throught the a connected device
timeFrame: Month 0, Month 3 and Month 6
measure: Sleep quality throught the Pittsburgh questionnaire
timeFrame: Month 0, Month 3 and Month 6
measure: Sleep quality throught the a connected device
timeFrame: Month 0, Month 3 and Month 6
measure: Treatment compliance at M3 and M6 through TAI (test inhaler adherence) questionnary
timeFrame: Month 3 and Month 6
measure: Baseline description of sociodemographic data and medical data through eCRF
timeFrame: baseline
measure: Treatment tolerance throughout the study through eCRF
timeFrame: up to 24 weeks
Other outcomes:
measure: Correlation between exacerbations occurrence and physical activity
timeFrame: Month 6
measure: Correlation between exacerbations occurrence and sleep quality
timeFrame: Month 6
measure: Correlation between QoL measured by VQ11 and the CAT through PROM
timeFrame: Month 0, Month 3 and Month 6
measure: Correlation between QoL measured with the VQ11 and Dyspnea-12 through PROM
timeFrame: Month 0, Month 3 and Month 6
measure: Among patients with the connected device, assess the correlation of sleep quality when measured with connected device and with the Pittsburgh Sleep Quality Index
timeFrame: Month 0, Month 3 and Month 6
measure: Dyspnoea with modified Medical Research Council (mMRC)
timeFrame: Month 0, Month 3 and Month 6
Locations:
city: Paris
country: France
facility: Pitié-Salpêtrière Hospital
Study officials:
affiliation: University Hospital, la pitié salpêtrière
name: Capucine MORELOT PANZINI, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: HOSPITAL, FOCH
name: Philippe DEVILLIER, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: European Hospital, Marseille
name: Hervé PEGLIASCO, Dr
role: PRINCIPAL_INVESTIGATOR
References: