Abstract
Background: Efficacy and safety of extra-fine beclomethasone dipropionate 100 μg/formoterol 6 μg pMDI (BDP/F) in adult patients with moderate-to-severe persistent asthma has been demonstrated in double-blind randomized controlled clinical trials.
Objective: To assess real-life effectiveness of BDP/F on asthma control.
Methods: Non-interventional, prospective, open-label, multicentre study in Belgium from December 2008 till December 2010. Patients were enrolled by pneumologists and general practitioners (GPs). Visit 1 (Day 0): demographic and baseline asthma control data collection, initiation of BDP/F treatment; Visit 2 (Day 61-240) and Visit 3 (Day 241-420): evaluation of asthma control by patients (Juniper ACQ7) and investigators (GINA asthma control score), assessment of BDP/F safety/tolerability.
Results: 619 patients were enrolled: mean age 48±16.9 years, 54% female, 22.8% smokers, mean FEV1% pred 78.6±20.0%. At visit 3 the mean daily beclomethasone dose was 266±127μg.
Similar improvements in asthma control, evaluated as patient-reported ACQ7 score or physician-rated GINA asthma control score, were observed in patients recruited by pneumologists and by GPs. Treatment-related non-serious adverse drug reactions were reported in 16 patients (2.6%).
Conclusion: The results of this study demonstrate the real-life effectiveness of extrafine BDP/F in adult patients with moderate-to-severe persistent asthma.
- © 2011 ERS