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 SAS
500 participants
Aug 1, 2023
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria5
- 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
Interventions
observational, prospective, multicentric, international, cohort study
Locations(1)
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NCT05948891