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

NCT05948891 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2024-03-13

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Kappa Santé

    collaborator INDUSTRY
  • Chiesi SAS

    lead INDUSTRY

Principal Investigators

  • Capucine MORELOT PANZINI, Pr · University Hospital, la pitié salpêtrière

  • Philippe DEVILLIER, Pr · HOSPITAL, FOCH

  • Hervé PEGLIASCO, Dr · European Hospital, Marseille

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2024-12-31
Completion
2025-03-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05948891 on ClinicalTrials.gov