Monitoring asthma patients using a single inhaler triple therapy in real-world settings
A Multicentre, Prospective, Non-interventional Trial Monitoring Therapy Pathways of Asthma Patients Treated With an Extra-fine ICS/LABA/LAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related Outcomes
This study is testing whether using a single inhaler with three asthma medications can help patients stick to their treatment and improve their health in everyday life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chiesi SAS Industry-sponsored |
| Locations | 1 site (Bois-Colombes) |
| Trial ID | NCT05728749 on ClinicalTrials.gov |
What this trial studies
TriMaximize is a non-interventional trial designed to collect prospective, longitudinal data from asthma patients receiving routine care who are prescribed Trimbow®, a single-inhaler triple therapy containing beclometasone, formoterol, and glycopyrronium. The study aims to evaluate patient adherence to this therapy and its impact on health-related outcomes. By focusing on patients who have been prescribed this treatment by their physicians, the trial seeks to gather insights into how a simplified inhaler regimen can improve adherence and overall asthma management. The data collected will help characterize the effects of this therapy in a real-world setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of asthma who are starting fixed triple therapy with Trimbow®.
Not a fit: Patients who are currently participating in an interventional clinical trial or those unable to understand the study's scope may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved adherence to asthma treatment and better health outcomes for patients.
How similar studies have performed: Other studies have shown success with similar approaches to asthma management, particularly with single-inhaler therapies improving adherence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients ≥ 18 years of age, * Patients with confirmed leading diagnosis of asthma with or without concomitant COPD, * Physician decision to start fixed triple therapy with ICS/LABA/LAMA (Trimbow® MS or HS) according to its current authorised indication. The treatment decision must be made independently from participation in this NIS, * Patients willing and able to sign an informed consent for use of their pseudonymised clinical data within the present non-interventional study, * Patient must be covered by a social security scheme, * Patient must be treated by one of the practitioners of the centre (at office or at hospital). Exclusion Criteria: * Participation in an interventional clinical trial within 30 days prior to enrolment into the present non-interventional study or planned enrolment in an interventional clinical trial during the observational period. * Patients unable to understand scope of study or patients unwilling to participate in study.
Where this trial is running
Bois-Colombes
- ChiesiFrance — Bois-Colombes, France (Recruiting)
Study contacts
- Principal investigator: Arnaud BOURDIN, Pr — University Hospital, Montpellier
- Study coordinator: Christine CONTRE, Dr
- Email: c.contre@chiesi.com
- Phone: +33675085149
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.