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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Pitié-Salpêtrière Hospital
RECRUITING
Paris
Contact Information
Primary
Christine Contré, Dr - Medical Director
c.contre@chiesi.com
+33147684121
Backup
Justine Fiocca, PHARM.D-Medical Advisor
j.fiocca@chiesi.com
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2025-03
Participants
Target number of participants: 500
Sponsors
Collaborators: Kappa Santé
Leads: Chiesi SAS

This content was sourced from clinicaltrials.gov