TriMaximize: A Multicentre, Prospective, Non-interventional Trial in Asthma Patients
- Conditions
- Asthma
- Registration Number
- NCT06567977
- Lead Sponsor
- Chiesi Poland Sp. z o.o.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
• 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. 12 months Primary outcome measures include:
Descriptive analisys of patients demografic
Descriptive analisys of patient demographic
- Secondary Outcome Measures
Name Time Method Treatment adherence 12 months - Assess treatment adherence - Change from baseline in TAI scores
Assess quality of life To measure the functional impairments 12 months - Assess quality of life - Change from baseline in Mini-AQLQ scores
Lung function 12 months - Analyse parameters of lung function using spirometry - Change from baseline in FEV1
Persistent airflow limitation 12 months - 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
Systemic corticosteroids use 12 months - Analyse use of systemic corticosteroids - Use of any systemic corticosteroids 12 months prior to baseline and during study
Small airways parameters 12 months - 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
Adverse events occurence 12 months - Assess adverse events associated with use of Trimbow - Assessment of the number and type of adverse events
Assess asthma control (ACT) 12 months - Assess asthma control (ACT) - Change from baseline in ACT scores
Airway inflammation 12 months - 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
Asthma exacerbations 12 months - Analyse the incidence of asthma exacerbations - Number of exacerbations 12 months prior to baseline and during study
Rescue medication use 12 months - Analyse use of rescue medication - Use of any rescue medication 7 days prior to baseline and during study 7 days prior to respective visit
Retention rate with Trimbow 12 months - Assess retention rate with Trimbow - Assess continuation of treatment with Trimbow (retention rate of Trimbow) at month 12
Trial Locations
- Locations (1)
Indywidualna Specjalistyczna Praktyka Lekarska
🇵🇱Tarnowskie Gory, Poland