TriMaximize, a non-interventional trial aims to collect prospective, longitudinal data from asthma patients under routine care, for whom their treating physician has decided to prescribe Trimbow® (beclometasone/formoterol/glycopyrronium).
TriMaximize, a non-interventional trial aims to collect prospective, longitudinal data from asthma patients under routine care, for whom their treating physician has decided to prescribe Trimbow® (beclometasone/formoterol/glycopyrronium). Trimbow is a fixed triple therapy containing a long-acting muscarinic antagonist (LAMA, glycopyrronium), a long-acting beta-adrenergic agonist (LABA, formoterol) and an inhaled corticosteroid (ICS, beclometasone). Asthma patients often need to use multiple inhalers as part of their therapy, which require different inhalation techniques. It has been shown that the use of several inhalers of different mode of action, design and dosage requirements may have a detrimental effect on patient adherence and subsequent treatment outcomes. In this prospective, non-interventional trial, the investigators aim to evaluate aspects of adherence to Trimbow, a single-inhaler triple therapy (SITT) as a maintenance treatment of asthma, to gather knowledge from routine care on whether appropriate step-up to SITT leads to greater adherence and better health outcomes.
Study Type
OBSERVATIONAL
Enrollment
300
As this is a non-interventional trial, only data obtained within the current routine management of asthma at outpatient respiratory centres or GP centres will be documented.
ChiesiFrance
Bois-Colombes, France
RECRUITINGTo describe patient characteristics and therapy pathways for patients with a diagnosis of moderate to severe asthma who are treated with Trimbow in real world practice
Descriptive analysis of patient demographics.
Time frame: 12 months
Assess asthma control (ACT)
Change from baseline in ACT scores.
Time frame: 12 months
Assess quality of life
Change from baseline in Mini-AQLQ scores.
Time frame: 12 months
Assess treatment adherence
Change from baseline in TAI scores.
Time frame: 12 months
Analyse parameters of lung function using spirometry
Change from baseline in FEV1.
Time frame: 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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 12 months
Analyse the incidence of asthma exacerbations
Number of exacerbations 12 months prior to baseline and during study.
Time frame: 12 months
Analyse the severity of asthma exacerbations as defined by the American Thoracic Society/European Respiratory Society (ATS/ERS) classification of asthma exacerbations
Severity of exacerbations, defined according to the ATS/ERS classification of asthma exacerbations, will be analysed 12 months prior to baseline and during study.
Time frame: 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.
Time frame: 12 months
Analyse use of systemic corticosteroids
Use of any systemic corticosteroids 12 months prior to baseline and during study.
Time frame: 12 months
Assess adverse events associated with use of Trimbow
Assessment of the number and type of adverse events.
Time frame: 12 months
Assess retention rate with Trimbow
Assess continuation of treatment with Trimbow (retention rate of Trimbow) at month 12.
Time frame: 12 months