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

July 4, 2023 updated by: Chiesi SAS
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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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,
  • Patient must be covered by a social security scheme,
  • Patient must be treated by one of the practitioners of the centre (at office or at hospital).

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.
  • Patients unable to understand scope of study or patients unwilling to participate in study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 12 months
Descriptive analysis of patient demographics.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess asthma control (ACT)
Time Frame: 12 months
Change from baseline in ACT scores.
12 months
Assess quality of life
Time Frame: 12 months
Change from baseline in Mini-AQLQ scores.
12 months
Assess treatment adherence
Time Frame: 12 months
Change from baseline in TAI scores.
12 months
Analyse parameters of lung function using spirometry
Time Frame: 12 months
Change from baseline in FEV1.
12 months
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.
12 months
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.
12 months
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.
12 months
Analyse the incidence of asthma exacerbations
Time Frame: 12 months
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
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.
12 months
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.
12 months
Analyse use of systemic corticosteroids
Time Frame: 12 months
Use of any systemic corticosteroids 12 months prior to baseline and during study.
12 months
Assess adverse events associated with use of Trimbow
Time Frame: 12 months
Assessment of the number and type of adverse events.
12 months
Assess retention rate with Trimbow
Time Frame: 12 months
Assess continuation of treatment with Trimbow (retention rate of Trimbow) at month 12.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiesi SAS

Collaborators

Gesellschaft für Therapieforschung mbH

Investigators

  • Principal Investigator: Arnaud BOURDIN, Pr, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

July 4, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS 005 Pn (Other Identifier: International unique identifier (Chiesi))
  • 564_TriMaximize_France (Other Identifier: Chiesi SAS)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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