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AsthmaTriMaximizeNCT04902573

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

An observational study of Asthma, run by Chiesi UK at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
What is being tested?
Non-interventional
How many people
147 participants
Where
1 siteUnited Kingdom
Study dates
17 Jun 2021to 14 Jun 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • The Haven Surgery, The Haven, Burnhope,

    Durham, County Durham, DH7 0BD

Other trials in United Kingdom

About this study

Official 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

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).

Read the 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.

Conditions
Asthma
Being tested
Non-interventional
Keywords
Trimbow, asthma, triple therapy, beclometasone, formoterol, glycopyrronium, Trimaximize
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-interventionalOther

    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.

Study groups in NCT04902573
Study groupRoleWhat they receive
Asthma patientsTrimbow pMDI prescribed for maintenance treatment of adult asthma as per the licensed indication.
Receives: Other: Non-interventional

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (13)

  1. Assess asthma control (ACT)

    Change from baseline in ACT scores

    Measured: 12 months

  2. Assess quality of life

    Change from baseline in Mini-AQLQ scores

    Measured: 12 months

  3. Assess treatment adherence

    Change from baseline in TAI scores

    Measured: 12 months

  4. Analyse parameters of lung function using spirometry

    Change from baseline in FEV1

    Measured: 12 months

  5. 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

    Measured: 12 months

  6. 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

    Measured: 12 months

  7. 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

    Measured: 12 months

  8. Analyse the incidence of asthma exacerbations

    Number of exacerbations 12 months prior to baseline and during study

    Measured: 12 months

  9. 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

    Measured: 12 months

  10. Analyse use of rescue medication

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

    Measured: 12 months

  11. Analyse use of systemic corticosteroids

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

    Measured: 12 months

  12. Assess adverse events associated with use of Trimbow

    Assessment of the number and type of adverse events

    Measured: 12 months

  13. Assess retention rate with Trimbow

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2021
  2. Study start17 Jun 2021
  3. Primary completion14 Jun 2024
  4. Study completion14 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04902573
Sponsor's protocol ID
548_TriMaximize
Other IDs
NIS 005 Pn, 294788
Acronym
TriMaximize
Status last verified
Sep 2025
First submitted
17 May 2021
Last updated
11 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by Chiesi UK at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04902573.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.

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