Clinical trial NCT06567977: TriMaximize: A Multicentre, Prospective, Non-interventional Trial in Asthma Patients
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma
Lead sponsor: Chiesi Poland Sp. z o.o.
Sponsor class: INDUSTRY
Collaborators: name: Gesellschaft für Therapieforschung mbH
First posted: 2024-08-23
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult asthmatic patients

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: Assess asthma control (ACT)
timeFrame: 12 months
measure: Assess quality of life To measure the functional impairments
timeFrame: 12 months
measure: Treatment adherence
timeFrame: 12 months
measure: Lung function
timeFrame: 12 months
measure: Small airways parameters
timeFrame: 12 months
measure: Airway inflammation
timeFrame: 12 months
measure: Persistent airflow limitation
timeFrame: 12 months
measure: Asthma exacerbations
timeFrame: 12 months
measure: Rescue medication use
timeFrame: 12 months
measure: Systemic corticosteroids use
timeFrame: 12 months
measure: Adverse events occurence
timeFrame: 12 months
measure: Retention rate with Trimbow
timeFrame: 12 months
Other outcomes:
Locations:
city: Tarnowskie Gory
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska
Study officials:
References: