title: Stepping-across controlled asthmatic patients to extrafine beclometasone/formoterol combination.
abstract: BACKGROUND
  Asthma management focuses on achieving and maintaining asthma control. Few studies have assessed whether complete and sustained asthma control is maintained in clinical practice after stepping-across ICS/LABA fixed combinations. Aim of this double-blind, double-dummy, randomized, parallel group, controlled study was to demonstrate clinical equivalence between equipotent doses of extrafine beclometasone/formoterol (BDP/F) pMDI and fluticasone/salmeterol (FP/S) Diskus® in maintaining lung function and asthma control.
  
  
  METHODS
  A total of 416 asthmatic patients already controlled with FP/S 500/100 μg/day (Diskus®, pMDI or separate inhalers) were randomized to a 12-week treatment with extrafine BDP/F 400/24 μg/day pMDI or FP/S 500/100 μg/day Diskus®. Pre-dose 1-s forced expiratory volume (FEV(1)) was the primary efficacy variable; secondary variables included asthma control questionnaire (ACQ-7) and FEV(1)0-1 h area under the curve (FEV(1)AUC(0-1h)). Safety was assessed through adverse events monitoring and vital signs.
  
  
  RESULTS
  After 12 weeks of treatment, pre-dose FEV(1) did not differ between treatments (difference between means 0.01 L; 95% CI -0.03-0.06 L) with no significant changes from baseline in both groups (p = 0.726 and p = 0.783 in BDF/F arm and FP/S, respectively). ACQ-7 score showed that control was maintained after stepping-across to extrafine BDP/F. FEV(1)AUC(0-1h) was significantly higher in BDP/F arm at the beginning (p = 0.004) and at the end of the 12-week treatment period (p = 0.019). No safety issues were reported in both groups.
  
  
  CONCLUSIONS
  Patients previously controlled with FP/S in any device formulation can effectively step-across to extrafine BDP/F pMDI, maintaining lung function and asthma control with a 5-min onset of action.
authors.affiliation: Department of Respiratory Medicine, London Chest Hospital, Barts & The London NHS Trust, Bonner Road, E2 9JX London, UK. neil.barnes@bartsandthelondon.nhs.uk
authors.forename: Neil
authors.initials: N
authors.lastname: Barnes
authors.forename: Jan Arie
authors.initials: JA
authors.lastname: van Noord
authors.forename: Caterina
authors.initials: C
authors.lastname: Brindicci
authors.forename: Ludger
authors.initials: L
authors.lastname: Lindemann
authors.forename: Guido
authors.initials: G
authors.lastname: Varoli
authors.forename: Miguel
authors.initials: M
authors.lastname: Perpiña
authors.forename: Daniele
authors.initials: D
authors.lastname: Guastalla
authors.forename: Daniela
authors.initials: D
authors.lastname: Casula
authors.forename: Shishir
authors.initials: S
authors.lastname: Patel
authors.forename: Pascal
authors.initials: P
authors.lastname: Chanez
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D000420:Albuterol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000730:Androstadienes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001507:Beclomethasone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D004983:Ethanolamines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D000068297:Fluticasone-Salmeterol Drug Combination; D005541:Forced Expiratory Volume; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D008875:Middle Aged; D010316:Particle Size; D012129:Respiratory Function Tests; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D004338:Drug Combinations; D004983:Ethanolamines; D000068297:Fluticasone-Salmeterol Drug Combination; D001507:Beclomethasone; D000420:Albuterol; D000068759:Formoterol Fumarate
keywords: Asthma control; Extrafine beclometasone/formoterol; Fluticasone/salmeterol; Lung function