title: Real-life effectiveness of extrafine beclometasone dipropionate/formoterol in adults with persistent asthma according to smoking status.
abstract: 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 β(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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Respiratory Medicine, Ghent University Hospital and Ghent University, De Pintelaan 185, B-9000 Ghent, Belgium. Guy.Brusselle@uzgent.be
authors.forename: Guy
authors.initials: G
authors.lastname: Brusselle
authors.forename: Rudi
authors.initials: R
authors.lastname: Peché
authors.forename: Paul
authors.initials: P
authors.lastname: Van den Brande
authors.forename: Albert
authors.initials: A
authors.lastname: Verhulst
authors.forename: Wim
authors.initials: W
authors.lastname: Hollanders
authors.forename: Jacques
authors.initials: J
authors.lastname: Bruhwyler
mesh_terms: D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D001507:Beclomethasone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D004983:Ethanolamines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D000068759:Formoterol Fumarate; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D008297:Male; D036501:Metered Dose Inhalers; D008875:Middle Aged; D010366:Peak Expiratory Flow Rate / Q000187:drug effects; D011446:Prospective Studies; D012907:Smoking / Q000009:adverse effects* / Q000503:physiopathology; D016896:Treatment Outcome
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D018927:Anti-Asthmatic Agents; D004338:Drug Combinations; D004983:Ethanolamines; D005938:Glucocorticoids; D001507:Beclomethasone; D000068759:Formoterol Fumarate