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

Chiesi

Status: Enrolling

Conditions: COPD

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

Study type: Observational

Funder types: Industry

Identifiers

NCT05948891

NIS 723

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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