TriMaximize: A Multicentre, Prospective, Non-interventional Trial in Asthma Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-31

Study Completion Date

2025-08-01

Brief Summary

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TriMaximize: 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.

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Detailed Description

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The goals of asthma therapy for all degrees of disease severity are minimising asthma symptoms, maximising lung function, and preventing asthma exacer-bations. Despite the existing treatment options and differentiated guidelines, 35 % to 45 % of the GINA 4/5 patients suffer from inadequately controlled symptoms. To investigate the cause of unsatisfactory treatment results, it is essential to monitor therapy pathways of asthma patients in a real-world set-ting. Resulting data can be compared to therapy guidelines and generate hy-potheses for future clinical trials.

Trimbow® is a fixed triple therapy containing a long-acting muscarinic antago-nist (LAMA, glycopyrronium), a long-acting beta-adrenergic agonist (LABA, formoterol) and an inhaled corticosteroid (ICS, beclomethasone). Trimbow® MS (medium strength) contains 100 µg beclomethasone whereas Trimbow® HS (high strength) contains 200 µg beclomethasone. Both formulations are investigated in this study.

Trimbow® has shown major clinical benefits in randomised controlled trials. However, the effects of Trimbow® on changes in patients' symptom burden and quality of life, adherence and clinical outcomes have not been yet as-sessed in a real-world asthma patient population.

The primary objective is to describe patient characteristics and therapy path-ways for patients with a diagnosis of moderate to severe asthma who are treated with Trimbow® in real world practice.

Secondary objectives include:

* To assess asthma control (ACT)
* To assess quality of life (Mini-AQLQ)
* To assess treatment adherence (TAI)
* To analyse parameters of lung function
* To analyse parameters of small airways disease (FEF 25-75, RV/TLC)
* To analyse parameters of asthma-related airway inflammation (FeNO)
* To analyse parameters of persistent airways limitation (reversibility testing FEV1/FVC)
* To analyse the incidence and the severity of asthma exacerbations
* To analyse the use of rescue medication
* To analyse the use of systemic corticosteroids
* To assess healthcare resource utilisation
* To assess treatment satisfaction with Trimbow®
* To assess tolerability of Trimbow® This is a non-interventional, longitudinal, international, multicentre study with prospective data collection. At baseline, the patient's medical history with spe-cial focus on asthma will be collected. The study baseline visit is at the time point of start of treatment with Trimbow®. Trimbow® treatment may have started up to a maximum of 4 weeks prior to inclusion of the patient into this NIS.

The planned observational period per patient should be at least 52 weeks (ob-servational period \[OP\] I of the study) and can be extended to up to 3 years (OP II of the study). During the observational period, data may be collected approximately every 3 months during the first year (OP I of the study) and thereafter every 6 months (OP II of the study). The present observational plan does not stipulate any study-related procedures or defined time points; only data that are available within the current clinical routine will be collected as documented in the patients' files.

Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Trimbow

Trimbow® is a fixed triple therapy containing a long-acting muscarinic antago-nist (LAMA, Glycopyrronium), a long-acting beta-adrenergic agonist (LABA, Formoterol) and an inhaled corticosteroid (ICS, beclomethasone). Trimbow® has an extra-fine formulation delivered as a controlled dosage aerosol. Trim-bow® is to be applied in accordance with its current marketing authorisation and the guidance specified in the summary of product characteristics (SmPC) in each country.

Intervention Type OTHER

Other Intervention Names

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Trimbow®

Eligibility Criteria

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No