title: Relief of methacholine-induced bronchospasm with extrafine beclomethasone dipropionate/formoterol in comparison with salbutamol in asthma.
abstract: BACKGROUND
  Short-acting beta2-agonists like salbutamol and terbutaline are used as rescue medications for acute bronchoconstriction and relief of symptoms due to their rapid onset of action. The aim of this study was to assess whether inhaled beclomethasone dipropionate (BDP)/formoterol fumarate (FF) combination in extrafine formulation is non-inferior to salbutamol in the speed of reverting methacholine-induced bronchoconstriction and symptoms.
  
  
  METHODS
  Fifty-six asthmatic patients were examined in a multicentre, randomised, double blind, double dummy, active treatment and placebo controlled three period cross-over study. On three different days, a single dose of BDP/FF 100/6 μg in pressurised metered-dose inhaler (pMDI) extrafine formulation or salbutamol 200 μg pMDI or placebo was inhaled after FEV(1) had dropped by 30-45% with methacholine challenge.
  
  
  RESULTS
  The median time to recovery of FEV(1) to 85% of baseline was similar for BDP/FF and salbutamol (3.66 and 2.15 min, respectively), but significantly longer for placebo (21.1 min). The planned analysis on adjusted mean time to recovery showed that the difference from methacholine-induced bronchoconstriction between BDP/FF and salbutamol was 3.82 min (95% confidence interval: -0.85 to 8.5), therefore greater than 3 min supposed in the study design. The difference between BDP/FF and salbutamol was not clinically significant. The two active treatments were also comparable in terms of the relief of symptoms (as assessed by the Borg dyspnoea scale).
  
  
  CONCLUSIONS
  BDP/FF combination has a fast onset of action, similar to that of salbutamol, and may represent a good alternative as rescue medication in asthmatic patients.
authors: University of Manchester, Medicines Evaluation Unit, University Hospital of South Manchester Foundation Trust, Manchester Academic Health Science Centre, Langley Building, Southmoor Road, Manchester M23 9QZ, UK. dsingh@meu.org.uk
authors: Dave
authors: D
authors: Singh
authors: Massimo
authors: M
authors: Corradi
authors: Eddi
authors: E
authors: Bindi
authors: Roberta
authors: R
authors: Baronio
authors: Stefano
authors: S
authors: Petruzzelli
authors: Pierluigi
authors: P
authors: Paggiaro
mesh_terms: D000328:Adult; D000420:Albuterol / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001507:Beclomethasone / Q000008:administration & dosage* / Q000009:adverse effects; D001986:Bronchial Spasm / Q000139:chemically induced / Q000188:drug therapy* / Q000503:physiopathology; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004983:Ethanolamines / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D016210:Methacholine Chloride / Q000494:pharmacology*; D008875:Middle Aged
chemical_list: D004983:Ethanolamines; D016210:Methacholine Chloride; D001507:Beclomethasone; D000420:Albuterol; D000068759:Formoterol Fumarate