Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Gesellschaft für Therapieforschung mbH | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trimbow | Other | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Primary outcome measures include: Descriptive analisys of patients demografic Descriptive analisys of patient demographic | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assess asthma control (ACT) | - Assess asthma control (ACT) - Change from baseline in ACT scores | 12 months |
| Assess quality of life To measure the functional impairments | - Assess quality of life - Change from baseline in Mini-AQLQ scores |
Not provided
Inclusion Criteria:
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.
Not provided
Not provided
Not provided
Not provided
Adult asthmatic patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tomasz Debowski, Md Phd | Contact | +48-800 506 122 982 | t.debowski@chiesi.com | |
| Maciej Wojakiewicz, Phd | Contact | +48-800 697 400 054 | m.wojakiewicz@chiesi.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indywidualna Specjalistyczna Praktyka Lekarska | Recruiting | Tarnowskie Góry | 42-609 | Poland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 months |
| Treatment adherence | - Assess treatment adherence - Change from baseline in TAI scores | 12 months |
| Lung function | - Analyse parameters of lung function using spirometry - Change from baseline in FEV1 | 12 months |
| Small airways parameters | - 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 | 12 months |
| Airway inflammation | - 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 | 12 months |
| Persistent airflow limitation | - 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 | 12 months |
| Asthma exacerbations | - Analyse the incidence of asthma exacerbations - Number of exacerbations 12 months prior to baseline and during study | 12 months |
| Rescue medication use | - Analyse use of rescue medication - Use of any rescue medication 7 days prior to baseline and during study 7 days prior to respective visit | 12 months |
| Systemic corticosteroids use | - Analyse use of systemic corticosteroids - Use of any systemic corticosteroids 12 months prior to baseline and during study | 12 months |
| Adverse events occurence | - Assess adverse events associated with use of Trimbow - Assessment of the number and type of adverse events | 12 months |
| Retention rate with Trimbow | - Assess retention rate with Trimbow - Assess continuation of treatment with Trimbow (retention rate of Trimbow) at month 12 | 12 months |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |