Observational study on asthma treatment pathways with triple therapy
Multicentre, Prospective, Non-interventional Study Monitoring Therapy Pathways of Asthma Patients Treated With an Extrafine ICS/LABA/LAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related Outcomes
This study looks at how well a specific asthma treatment combining three medications works for patients getting regular care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chiesi Farmaceutici S.p.A. Industry-sponsored |
| Locations | 1 site (Genoa) |
| Trial ID | NCT06100042 on ClinicalTrials.gov |
What this trial studies
TriMaximize is a non-interventional study designed to gather prospective data from patients with asthma who are receiving routine care. The study focuses on individuals who have been prescribed a fixed triple therapy regimen consisting of beclomethasone, formoterol, and glycopyrronium. The treatment decision is made by the physician independently of the study, and data will be collected on the therapy pathways followed by these patients 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.
Not a fit: Patients currently participating in an interventional clinical trial or those who have recently participated in one may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and real-world application of triple therapy for asthma management.
How similar studies have performed: Other studies have explored therapy pathways in asthma, but this specific observational approach focusing on triple therapy is relatively novel.
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 (BDP/FF/G) MS or HS according to its current authorised indication and current reimbursement conditions within the Italian National Health System. The treatment decision must be made independently from participation in this study and may have started within the previous 4 weeks (maximum); * Patients willing and able to sign an informed consent for use of their pseudonymised clinical data within the present non-interventional study. 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.
Where this trial is running
Genoa
- U.O. Clinica Psichiatrica e SPDC. Ospedale Policlinico S. Martino - IRCCS, Genova — Genoa, Italy (Recruiting)
Study contacts
- Study coordinator: Clinical Trial Info
- Email: clinicaltrials_info@chiesi.com
- Phone: 0521 2791
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.