Evaluating the impact of a new COPD treatment on patient quality of life
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
This study is testing if a new COPD treatment can improve the quality of life for patients over six months while also tracking their activity and sleep with a connected watch.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Chiesi SAS Industry-sponsored |
| Locations | 1 site (Paris) |
| Trial ID | NCT05948891 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the quality of life in patients with Chronic Obstructive Pulmonary Disease (COPD) who are treated with the fixed triple therapy Beclometasone/Formoterol/Glycopyrronium using the NEXThaler device. Conducted in France, the study will follow patients over a period of six months, with three scheduled visits to monitor their health and gather patient-reported outcome measures (PROMs). Additionally, half of the participants will be invited to wear a connected watch to track their physical activity and sleep quality, providing a comprehensive view of their health in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 and older with a confirmed diagnosis of COPD and a specific lung function ratio.
Not a fit: Patients with asthma or those who have had recent exacerbations or treatments that conflict with the study criteria may not benefit.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of how the new treatment impacts the quality of life for COPD patients.
How similar studies have performed: Other studies have shown promising results with similar approaches in evaluating treatment impacts on quality of life in COPD patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paris
- Pitié-Salpêtrière Hospital — Paris, France (Recruiting)
Study contacts
- Principal investigator: Capucine MORELOT PANZINI, Pr — University Hospital, la pitié salpêtrière
- Study coordinator: Christine Contré, Dr - Medical Director
- Email: c.contre@chiesi.com
- Phone: +33147684121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.