Asthma
Conditions
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.
Interventions
OTHERTrimbow
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.
Sponsors
Gesellschaft für Therapieforschung mbH
Chiesi Poland Sp. z o.o.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Assess quality of life To measure the functional impairments | 12 months | \- Assess quality of life - Change from baseline in Mini-AQLQ scores |
| Treatment adherence | 12 months | \- Assess treatment adherence - Change from baseline in TAI scores |
| Lung function | 12 months | \- Analyse parameters of lung function using spirometry - Change from baseline in FEV1 |
| 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 |
| 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 |
| Assess asthma control (ACT) | 12 months | \- Assess asthma control (ACT) - Change from baseline in ACT scores |
| 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 |
| Systemic corticosteroids use | 12 months | \- Analyse use of systemic corticosteroids - Use of any systemic corticosteroids 12 months prior to baseline and during study |
| Adverse events occurence | 12 months | \- Assess adverse events associated with use of Trimbow - Assessment of the number and type of adverse events |
| Retention rate with Trimbow | 12 months | \- Assess retention rate with Trimbow - Assess continuation of treatment with Trimbow (retention rate of Trimbow) at month 12 |
| 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 |
Countries
Poland
Contacts
Primary ContactTomasz Debowski, Md Phd
Backup ContactMaciej Wojakiewicz, Phd
Outcome results
None listed