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

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).

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Other: Non-interventional

Detailed Description

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).

Trimbow is a fixed triple therapy containing a long-acting muscarinic antagonist (LAMA, glycopyrronium), a long-acting beta-adrenergic agonist (LABA, formoterol) and an inhaled corticosteroid (ICS, beclometasone).

Asthma patients often need to use multiple inhalers as part of their therapy, which require different inhalation techniques. It has been shown that the use of several inhalers of different mode of action, design and dosage requirements may have a detrimental effect on patient adherence and subsequent treatment outcomes.

In this prospective, non-interventional trial, the investigators aim to evaluate aspects of adherence to Trimbow, a single-inhaler triple therapy (SITT) as a maintenance treatment of asthma, to gather knowledge from routine care on whether appropriate step-up to SITT leads to greater adherence and better health outcomes.

• Study Type: Observational
• Enrollment (Actual): 147

Contacts and Locations

Study Locations

• United Kingdom
  • County Durham
    • Durham, County Durham, United Kingdom, DH7 0BD
      • The Haven Surgery, The Haven, Burnhope,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. Patients ≥ 18 years of age,
2. Patients with confirmed leading diagnosis of asthma with or without concomitant COPD,
3. 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,
4. Patients willing and able to sign an informed consent for use of their pseudonymised clinical data within the present non-interventional study.

Exclusion Criteria:

1) 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Asthma patients; Trimbow pMDI prescribed for maintenance treatment of adult asthma as per the licensed indication.	Other: Non-interventional; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess asthma control (ACT)	Change from baseline in ACT scores	12 months
Assess quality of life	Change from baseline in Mini-AQLQ scores	12 months
Assess treatment adherence	Change from baseline in TAI scores	12 months
Analyse parameters of lung function using spirometry	Change from baseline in FEV1	12 months
Analyse parameters of small airways disease	Change from baseline in small airway function measured by pre-dose AUCAX (Area under the curve of reactance) using available oscillometry system	12 months
Analyse parameters of asthma-related airway inflammation	Change from baseline in percentage of patients with a fraction of exhaled nitric oxide (FeNO) below or above 20 ppb	12 months
Analyse parameters of persistent airflow limitation	Change from baseline in percentage of patients with persistent airflow limitation (PAL); PAL defined as post-BD FEV1 <80% predicted and post-BD FEV1/FVC Ratio < 0.7	12 months
Analyse the incidence of asthma exacerbations	Number of exacerbations 12 months prior to baseline and during study	12 months
Analyse the severity of asthma exacerbations as defined by the American Thoracic Society/European Respiratory Society (ATS/ERS) classification of asthma exacerbations	Severity of exacerbations, defined according to the ATS/ERS classification of asthma exacerbations, will be analysed 12 months prior to baseline and during study	12 months
Analyse use of rescue medication	Use of any rescue medication 7 days prior to baseline and during study 7 days prior to respective visit	12 months
Analyse use of systemic corticosteroids	Use of any systemic corticosteroids 12 months prior to baseline and during study	12 months
Assess adverse events associated with use of Trimbow	Assessment of the number and type of adverse events	12 months
Assess retention rate with Trimbow	Assess continuation of treatment with Trimbow (retention rate of Trimbow) at month 12	12 months

Collaborators and Investigators

• Sponsor: Chiesi UK
• Collaborators: Gesellschaft für Therapieforschung mbH
• Investigators: Principal Investigator: Richard Russell, PhD, MBBS, University of Oxford

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2021
• Primary Completion (Actual): June 14, 2024
• Study Completion (Actual): June 14, 2024

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: asthma; formoterol; triple therapy; glycopyrronium; Trimbow; beclometasone; Trimaximize
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: 548_TriMaximize; NIS 005 Pn (Other Identifier: International unique identifier (Chiesi)); 294788 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No