RATIONALE
A multicenter prospective non-interventional TRIal monitoring therapy pathways of asthMA patients treated with an eXtrafIne ICS/LABA/LAMA single-Inhaler triple therapy in a real-world setting and characteriZing the Effects on health-related outcomes
METHODS
Study Design
* Premedication: ICS/LABA or ICS/LABA/LAMA (open or fixed)
** Visits every 3 months
*** Visits every 6 months
OP: Observational period; ICS: Inhaled corticosteroid; LABA: Long-acting beta-2-agonist; LAMA: Long-acting muscarinic antagonist
Objectives
Primary objective
To describe patient characteristics and therapy pathways for patients with a diagnosis of moderate to severe asthma who are treated with extrafine BDP/FF/GG in real-world practice.
Secondary objectives include
- To assess asthma control, quality of life, treatment adherence, healthcare resource utilization, treatment satisfaction with and tolerability of extrafine BDP/FF/G.
- To analyze parameters of lung function, the incidence and the severity of asthma exacerbations, the use of rescue medication, the use of systemic corticosteroids.
BDP: Beclomethasone dipropionate; FF: Formoterol fumarate; G: Glycopyrronium bromide
Study Population
- Patients at least 18 years of age,
- Patients with confirmed leading diagnosis of asthma with or without concomitant COPD,
- Patients willing and able to sign an informed consent for use of their pseudonymized clinical data within the present study,
- Physician’s decision to start therapy with BDP/FF/G (i) according to its current authorized indication, and (ii) made independently from participation in this study.
RESULTS
Here we report descriptive baseline characteristics of the first 260 patients from 47 German centers.
SD: Standard deviation; BMI: Body mass index; HCRU: Healthcare resource utilization; ACT: Asthma Control Test; Mini AQLQ: Mini Asthma Quality of Life Questionnaire; TAI: Test of Adherence to Inhalers
SD: Standard deviation; BMI: Body mass index; HCRU: Healthcare resource utilization; ACT: Asthma Control Test; Mini AQLQ: Mini Asthma Quality of Life Questionnaire; TAI: Test of Adherence to Inhalers
BDP: Beclomethasone dipropionate; FF: Formoterol fumarate; G: Glycopyrronium bromide; ICS: Inhaled corticosteroid; LABA: Long-acting beta-2-agonist; LAMA: Long-acting muscarinic antagonist
Figure 4: Main reason for being prescribed extrafine BDP/FF/G
BDP: Beclomethasone dipropionate; FF: Formoterol fumarate; G: Glycopyrronium bromide; ICS: Inhaled corticosteroid; LABA: Long-acting beta-2-agonist; LAMA: Long-acting muscarinic antagonist
Figure 4: Main reason for being prescribed extrafine BDP/FF/G
CONCLUSIONS
These real-world data in 260 patients with asthma in Germany display a patient population with poorly controlled asthma despite receiving ICS/LABA or ICS/LABA/LAMA. The significant effect of asthma on health-related quality of life and healthcare resource utilization in this population calls for a re-evaluation of their asthma therapy with special attention to treatment intensity and adherence.