TriMaximize: 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

Sponsor

Chiesi UK (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04902573

Collaborator

Gesellschaft für Therapieforschung mbH (Industry)

200

Enrollment

Location

23.5

Anticipated Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Asthma	Other: Non-interventional

Detailed Description

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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Jun 17, 2021

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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 [12 months]
Descriptive analysis of patient demographics

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.