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 (TriNEXT)

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.

Study Overview

• Status: Recruiting
• Conditions: COPD
• Intervention / Treatment: Drug: Beclometasone/Formoterol/Glycopyrronium 88 µg/5 µg/9 µg DPI (Trimbow® 88 µg/5 µg/9 µg in NEXThaler device)

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Christine Contré, Dr - Medical Director; Phone Number: +33147684121; Email: c.contre@chiesi.com
• Study Contact Backup: Name: Justine Fiocca, PHARM.D-Medical Advisor; Email: j.fiocca@chiesi.com

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Pitie-Salpêtrière Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change Quality of life through VQ11 questionnaire	To assess change in QoL using the VQ11 scale over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device • Endpoint is mean VQ11 total score and sub scores described at baseline, M3 and M6	Month 0, Month 3 and Month 6
Proportion of patients achieving a ≥2-point reduction in VQ11 total score	To assess change in QoL using the VQ11 scale over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device • Endpoint is the proportion of patients achieving a ≥2-point reduction in VQ11 total score (MCID) at M3 and M6 compared to baseline.	Month 0, Month 3 and Month 6
Mean change in Dyspnoea throught "Dyspnea-12 questionnaire"	To assess changes in dyspnoea using the Dyspnea-12 over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device • Endpoint is D-12 total score and sub scores described at baseline, M3 and M6	Month 0, Month 3 and Month 6
Proportion of patients achieving a 3-point reduction in "Dyspnea-12" total score	To assess changes in dyspnoea using the Dyspnea-12 over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device • Endpoint is the proportion of patients achieving a 3-point reduction in D-12 total score (MCID) at M3 and M6 compared to baseline.	Month 0, Month 3 and Month 6
Rate of moderate and severe exacerbations at M0, M3 and M6 through eCRF	To describe the occurrence of moderate to severe exacerbations over a 6- month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device Endpoint is the proportion of patients with at least a moderate or severe exacerbation (overall and in each category), at baseline (in the previous 12 months), M3 and M6	Month 0, Month 3 and Month 6
Proportion of patients achieving an increase in physical activity throught the a connected device	To assess changes in physical activity using a connected watch over a 6-month • Endpoint is the proportion of patients achieving an increase in physical activity (≥ 10%-increase in the mean daily number of step) at M3 and M6 compared to baseline. Baseline physical activity (M0) will be defined as the mean of data collected during the first 7 days of connected device wearing watch over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device	Month 0, Month 3 and Month 6
Mean daily number of steps throught the a connected device	To assess changes in physical activity using a connected watch over a 6-month • Endpoints are the mean daily number of steps and the mean of number of steps during 7 days at M0, M3 and M6 Baseline physical activity (M0) will be defined as the mean of data collected during the first 7 days of connected device wearing watch over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device	Month 0, Month 3 and Month 6
Sleep quality throught the Pittsburgh questionnaire	• Endpoints are the Pittsburgh questionnaire at M0, M3 and M6 Baseline physical activity (M0) will be defined as the mean of data collected during the first 7 days of connected device wearing.	Month 0, Month 3 and Month 6
Sleep quality throught the a connected device	To assess changes in sleep quality using a connected device • Endpoints are the mean daily sleep time, the mean of sleep time and the mean daily number of awakenings during 7 days at M0, M3 and M6 Baseline sleep quality (M0) will be defined as the mean of data collected during the first 7 days of connected device wearing.	Month 0, Month 3 and Month 6
Treatment compliance at M3 and M6 through TAI (test inhaler adherence) questionnary	To assess treatment compliance with BDP/FF/G (88/5/9) in NEXThaler® device • Endpoint is the description of treatment compliance global score at M3 and M6 for COPD using TAI	Month 3 and Month 6
Baseline description of sociodemographic data and medical data through eCRF	to describe COPD patient, disease and treatment characteristics at initiation of BDP/FF/G (88/5/9) in NEXThaler® device; Endpoints are description of sociodemographic (age, sex, weight, height, education level, occupation), medical data (risk factors exposure including tobacco, disease history) and lung function data (FEV1, FVC, RV, TLC) at baseline; Endpoints are description of comorbidities and associated treatment throughout the study at baseline; Endpoints are description of previous COPD-related treatment at baseline through eCRF	baseline
Treatment tolerance throughout the study through eCRF	To assess treatment tolerance in COPD patients treated with with BDP/FF/G (88/5/9) in NEXThaler® device To assess patient satisfaction with treatment in COPD patients treated with BDP/FF/GB NEXThaler® 88/5/9	up to 24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between exacerbations occurrence and physical activity	To assess the association between exacerbations occurrence and physical activity changes Physical activity measured by a connected device over a 6-month follow-up	Month 6
Correlation between exacerbations occurrence and sleep quality	To assess the association between exacerbations occurrence sleep quality changes Sleep quality changes measured by a connected device over a 6-month follow-up period in COPD patients treated with BDP/FF/G (88/5/9) in NEXThaler® device for COPD	Month 6
Correlation between QoL measured by VQ11 and the CAT through PROM	To assess the correlation between QoL measured with the VQ11 and the CAT for COPD • Endpoints are value of the Pearson correlation test described at baseline, M3 and M6	Month 0, Month 3 and Month 6
Correlation between QoL measured with the VQ11 and Dyspnea-12 through PROM	To assess the correlation between QoL measured with the VQ11 and Dyspnea-12 for COPD • Endpoints are value of the Pearson correlation test described at baseline, M3 and M6	Month 0, Month 3 and Month 6
Among patients with the connected device, assess the correlation of sleep quality when measured with connected device and with the Pittsburgh Sleep Quality Index	Among COPD patients with the connected device, to assess the correlation of sleep quality when measured with connected device and with the Pittsburgh Sleep Quality Index • Endpoints are value of the Pearson correlation test described at baseline, M3 and M6	Month 0, Month 3 and Month 6
Dyspnoea with modified Medical Research Council (mMRC)	Endpoint is mMRC total score described at baseline, M3 and M6	Month 0, Month 3 and Month 6

Collaborators and Investigators

• Sponsor: Chiesi SAS
• Collaborators: Kappa Santé
• Investigators: Principal Investigator: Capucine MORELOT PANZINI, Pr, University Hospital, la pitié salpêtrière; Principal Investigator: Philippe DEVILLIER, Pr, HOSPITAL, FOCH; Principal Investigator: Hervé PEGLIASCO, Dr, European Hospital, Marseille

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: June 30, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; Adult; PRO; observational; Chronic obstructive pulmonary disease (COPD); QOL; Digital; respiratory diseases; PROMS; connected device
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Beclomethasone; Glycopyrrolate; Formoterol Fumarate
• Other Study ID Numbers: NIS 723

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No