A Trial 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 Out-comes
TriMaximize
A Multicentre, Prospective, Non-interventional Trial 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 Out-comes
3 other identifiers
observational
147
1 country
1
Brief Summary
TriMaximize, a non-interventional trial aims to collect prospective, longitudinal data from asthma patients under routine care, for whom their treating physician has decided to prescribe Trimbow® (beclometasone/formoterol/glycopyrronium).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2021
CompletedFirst Posted
Study publicly available on registry
May 26, 2021
CompletedStudy Start
First participant enrolled
June 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2024
CompletedSeptember 11, 2025
September 1, 2025
3 years
May 17, 2021
September 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To describe patient characteristics and therapy pathways for patients with a diagnosis of moderate to severe asthma who are treated with Trimbow in real world practice
Descriptive analysis of patient demographics
12 months
Secondary Outcomes (13)
Assess asthma control (ACT)
12 months
Assess quality of life
12 months
Assess treatment adherence
12 months
Analyse parameters of lung function using spirometry
12 months
Analyse parameters of small airways disease
12 months
- +8 more secondary outcomes
Study Arms (1)
Asthma patients
Trimbow pMDI prescribed for maintenance treatment of adult asthma as per the licensed indication.
Interventions
As this is a non-interventional trial, only data obtained within the current routine management of asthma at outpatient respiratory centres or GP centres will be documented.
Eligibility Criteria
Patients will only be included in the Non-Interventional Trial if Trimbow® has been prescribed in line with its current marketing authorisation and the guidance specified in the summary of product characteristics (SmPC). Physicians are urged to offer enrolment to all of their eligible patients consecutively as they present for their routine visit, and not select patients from their patient database. Eligible patients may only be included in the NIT after providing written (witnessed, where required by law or regulation), IEC-approved informed consent.
You may qualify if:
- 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.
You may not qualify if:
- \) 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chiesi UKlead
- Gesellschaft für Therapieforschung mbHcollaborator
Study Sites (1)
The Haven Surgery, The Haven, Burnhope,
Durham, County Durham, DH7 0BD, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Russell, PhD, MBBS
University of Oxford
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2021
First Posted
May 26, 2021
Study Start
June 17, 2021
Primary Completion
June 14, 2024
Study Completion
June 14, 2024
Last Updated
September 11, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share