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 | Recruiting

• 1 other identifier: NIS 723
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

Digital; QOL; PROMS; PRO; respiratory diseases; Chronic obstructive pulmonary disease (COPD); Adult; observational; connected device; quality of life

Outcome Measures

Primary Outcomes (1)

• Change of quality of life through CAT (COPD assessement tool) over 6 month period

  To assess change in QoL using the CAT scale over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device • Primary endpoint is the proportion of patients achieving a ≥2-point reduction in CAT total score (MCID) at M6 compared to baseline.

  Month 6

Secondary Outcomes (12)

• Mean change Quality of life through VQ11 questionnaire

  Month 0, Month 3 and Month 6

• Proportion of patients achieving a ≥2-point reduction in VQ11 total score

  Month 0, Month 3 and Month 6

• Mean change in Dyspnoea throught "Dyspnea-12 questionnaire"

  Month 0, Month 3 and Month 6

• Proportion of patients achieving a 3-point reduction in "Dyspnea-12" total score

  Month 0, Month 3 and Month 6

• Rate of moderate and severe exacerbations at M0, M3 and M6 through eCRF

  Month 0, Month 3 and Month 6

Other Outcomes (6)

• Correlation between exacerbations occurrence and physical activity

  Month 6

• Correlation between exacerbations occurrence and sleep quality

  Month 6

• Correlation between QoL measured by VQ11 and the CAT through PROM

  Month 0, Month 3 and Month 6

Interventions

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

observational, prospective, multicentric, international, cohort study

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• Informed consent to participate in the study

You may not qualify if:

• Asthmatic patients
• Patients with moderate or severe exacerbations within the 4 weeks prior to enrolment
• Concomitant participation in experimental clinical studies/investigations or participation in experimental clinical studies/investigations within 3 months prior to enrolment into the present study

Sponsors & Collaborators

• Chiesi SAS: lead
• Kappa Santé: collaborator

Study Sites (1)

Pitié-Salpêtrière Hospital

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases

Interventions

Beclomethasone; Formoterol Fumarate; Glycopyrrolate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Quaternary Ammonium Compounds; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Capucine MORELOT PANZINI, Pr

  University Hospital, la pitié salpêtrière

  PRINCIPAL INVESTIGATOR

• Philippe DEVILLIER, Pr

  HOSPITAL, FOCH

  PRINCIPAL INVESTIGATOR

• Hervé PEGLIASCO, Dr

  European Hospital, Marseille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Contré, Dr - Medical Director

CONTACT

+33147684121; c.contre@chiesi.com

Justine Fiocca, PHARM.D-Medical Advisor

CONTACT

j.fiocca@chiesi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 17, 2023
• Study Start: August 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

FR (1)