SummaryBackgroundThe 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.MethodsAdult patients with persistent asthma, in whom treatment with an inhaled corticosteroid/long-acting β2-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.ResultsOverall, 619 patients were enrolled by 97 investigators. In the effectiveness cohort (N = 568), at baseline, smoking asthmatics (N = 123) had higher ACQ6 (p