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Completed

NCT Number: NCT04902573

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 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).

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Haven Surgery, The Haven, Burnhope,

Durham, County Durham, DH7 0BD, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 enrolment into the present non-interventional study or planned enrolment in an interventional clinical trial during the observational period.

Treatment and study plan

Non-Interventional

Other

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.

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

    Time frame: 12 months

    Descriptive analysis of patient demographics

Secondary outcomes

  1. Assess asthma control (ACT)

    Time frame: 12 months

    Change from baseline in ACT scores

  2. Assess quality of life

    Time frame: 12 months

    Change from baseline in Mini-AQLQ scores

  3. Assess treatment adherence

    Time frame: 12 months

    Change from baseline in TAI scores

  4. Analyse parameters of lung function using spirometry

    Time frame: 12 months

    Change from baseline in FEV1

  5. Analyse parameters of small airways disease

    Time frame: 12 months

    Change from baseline in small airway function measured by pre-dose AUCAX (Area under the curve of reactance) using available oscillometry system

  6. Analyse parameters of asthma-related airway inflammation

    Time frame: 12 months

    Change from baseline in percentage of patients with a fraction of exhaled nitric oxide (FeNO) below or above 20 ppb

  7. Analyse parameters of persistent airflow limitation

    Time frame: 12 months

    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

  8. Analyse the incidence of asthma exacerbations

    Time frame: 12 months

    Number of exacerbations 12 months prior to baseline and during study

  9. Analyse the severity of asthma exacerbations as defined by the American Thoracic Society/European Respiratory Society (ATS/ERS) classification of asthma exacerbations

    Time frame: 12 months

    Severity of exacerbations, defined according to the ATS/ERS classification of asthma exacerbations, will be analysed 12 months prior to baseline and during study

  10. Analyse use of rescue medication

    Time frame: 12 months

    Use of any rescue medication 7 days prior to baseline and during study 7 days prior to respective visit

  11. Analyse use of systemic corticosteroids

    Time frame: 12 months

    Use of any systemic corticosteroids 12 months prior to baseline and during study

  12. Assess adverse events associated with use of Trimbow

    Time frame: 12 months

    Assessment of the number and type of adverse events

  13. Assess retention rate with Trimbow

    Time frame: 12 months

    Assess continuation of treatment with Trimbow (retention rate of Trimbow) at month 12

Sponsors and collaborators

Lead sponsor

Chiesi UK

Industry

Collaborators

  • Gesellschaft für Therapieforschung mbH

Registry information

Official study title

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

Acronym: TriMaximize

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 26, 2021
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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