title: Extrafine beclomethasone/formoterol compared to fluticasone/salmeterol combination therapy in COPD.
abstract: BACKGROUND
  The study evaluated the efficacy of beclomethasone dipropionate/formoterol fumarate (BDP/FF) extrafine combination versus fluticasone propionate/salmeterol (FP/S) combination in COPD patients.
  
  
  METHODS
  The trial was a 12-week multicentre, randomised, double-blind, double dummy study; 419 patients with moderate/severe COPD were randomised to BDP/FF 200/12 μg or FP/S 500/50 μg twice daily. The primary objective was to demonstrate the equivalence between treatments in terms of Transition Dyspnoea Index (TDI) score and the superiority of BDP/FF in terms of change from pre-dose in the first 30 minutes in forced expiratory volume in the first second (FEV1). Secondary endpoints included lung function, symptom scores, symptom-free days and use of rescue medication, St. George's Respiratory Questionnaire, six minute walking test and COPD exacerbations.
  
  
  RESULTS
  BDP/FF was equivalent to FP/S in terms of TDI score and superior in terms of FEV1 change from pre-dose (p < 0.001). There were no significant differences between treatments in secondary outcome measures, confirming overall comparability in terms of efficacy and tolerability. Moreover, a clinically relevant improvement (>4 units) in SGRQ was detected in the BDP/FF group only.
  
  
  CONCLUSIONS
  BDP/FF extrafine combination provides COPD patients with an equivalent improvement of dyspnoea and a faster bronchodilation in comparison to FP/S.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01245569.
authors.affiliation: University of Manchester, Medicines Evaluation Unit, University Hospital of South Manchester Foundation Trust, Manchester, UK. DSingh@meu.org.uk.
authors.forename: Dave
authors.initials: D
authors.lastname: Singh
authors.forename: Gabriele
authors.initials: G
authors.lastname: Nicolini
authors.forename: Eddi
authors.initials: E
authors.lastname: Bindi
authors.forename: Massimo
authors.initials: M
authors.lastname: Corradi
authors.forename: Daniele
authors.initials: D
authors.lastname: Guastalla
authors.forename: Jorg
authors.initials: J
authors.lastname: Kampschulte
authors.forename: Władysław
authors.initials: W
authors.lastname: Pierzchała
authors.forename: Abdullah
authors.initials: A
authors.lastname: Sayiner
authors.forename: Mária
authors.initials: M
authors.lastname: Szilasi
authors.forename: Claudio
authors.initials: C
authors.lastname: Terzano
authors.forename: Jørgen
authors.initials: J
authors.lastname: Vestbo
mesh_terms: D000420:Albuterol / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000730:Androstadienes / Q000627:therapeutic use*; D001507:Beclomethasone / Q000008:administration & dosage*; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D004338:Drug Combinations; D004983:Ethanolamines / Q000008:administration & dosage*; D005260:Female; D000068297:Fluticasone-Salmeterol Drug Combination; D000068759:Formoterol Fumarate; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*
chemical_list: D000730:Androstadienes; D001993:Bronchodilator Agents; D004338:Drug Combinations; D004983:Ethanolamines; D000068297:Fluticasone-Salmeterol Drug Combination; D005938:Glucocorticoids; D001507:Beclomethasone; D000420:Albuterol; D000068759:Formoterol Fumarate