trimaximize: a multicentre, prospective, non-interventional trial in asthma patients

Conditions: Asthma

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.

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.