RESUMEN
BACKGROUND: The efficacy and safety of extrafine beclomethasone dipropionate 100 µg/formoterol 6 µg (BDP/F HFA) pressurized metered dose inhaler (pMDI) in patients with moderate-to-severe persistent asthma, has been demonstrated in randomised controlled trials (RCTs). The aim of this prospective observational study was to assess real-life effectiveness in terms of asthma control in smoking (most of the time excluded from RCTs) and non-smoking asthmatics. METHODS: Adult patients with persistent asthma, in whom treatment with an inhaled corticosteroid/long-acting ß(2)-agonist (ICS/LABA) combination is indicated, were included. Pulmonary function (FEV1%pred or PEF absolute value), Asthma Control Questionnaire (ACQ) and asthma control according to GINA criteria were measured at baseline as well as 2-8 months and >8-14 months after treatment initiation with BDP/F HFA. RESULTS: Overall, 619 patients were enrolled by 97 investigators. In the effectiveness cohort (N = 568), at baseline, smoking asthmatics (N = 123) had higher ACQ6 (p < 0.0001) and lower asthma control (p = 0.021) than non-smoking asthmatics. Treatment with BDP/F HFA pMDI was associated with significant (p < 0.0001) improvements in pulmonary function (+7.1% in FEV1% pred), ACQ6 (-1.32) and GINA asthma control (improvement of control in 49.8% of patients). Importantly, the same treatment benefits were observed in former or current smokers compared with non-smoking asthmatics. There was a reduction in the dose of ICS from 489 ± 192 µg BDP extrafine equivalents at baseline to 265 ± 125 µg after one year. The drug was well-tolerated. CONCLUSION: This prospective cohort study demonstrates the real-life effectiveness and safety of BDP/F HFA in adult asthma patients, including smokers, in normal clinical practice.