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.