Monitoring asthma patients using a new inhaler therapy
TriMaximize: 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 a new inhaler treatment for asthma to see how well it helps patients manage their symptoms and improve their quality of life in everyday situations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Sex | All |
| Sponsor | Chiesi Poland Sp. z o.o. Industry-sponsored |
| Locations | 1 site (Tarnowskie Góry) |
| Trial ID | NCT06567977 on ClinicalTrials.gov |
What this trial studies
This trial monitors therapy pathways of asthma patients treated with Trimbow®, a single-inhaler triple therapy, in a real-world setting. It aims to characterize the effects of this treatment on health-related outcomes, including symptom control and quality of life. The study will collect data on patient characteristics and therapy adherence, comparing real-world results to established treatment guidelines. The findings may help identify reasons for inadequate symptom control in asthma patients and inform future clinical trials.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of moderate to severe asthma who are starting treatment with Trimbow®.
Not a fit: Patients currently participating in other interventional clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve asthma management and patient outcomes by providing insights into effective treatment pathways.
How similar studies have performed: Previous studies have shown clinical benefits of Trimbow® in controlled settings, but this study is novel in its focus on real-world outcomes.
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. Exclusion Criteria: • Participation in an interventional clinical trial within 30 days prior to en-rolment into the present non-interventional study or planned enrolment in an interventional clinical trial during the observational period.
Where this trial is running
Tarnowskie Góry
- Indywidualna Specjalistyczna Praktyka Lekarska — Tarnowskie Góry, Poland (Recruiting)
Study contacts
- Study coordinator: Tomasz Debowski, Md Phd
- Email: t.debowski@chiesi.com
- Phone: +48-800 506 122 982
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.