title: Faster onset of bronchodilation with formoterol than with salmeterol in patients with stable, moderate to severe COPD: results of a randomized, double-blind clinical study.
abstract: OBJECTIVE
  To compare the onset and magnitude of bronchodilation after dry powder inhalations of formoterol fumarate (Foradil Aerolizer) versus salmeterol xinofoate (Serevent Diskus) with respect to normalized (*) forced expiratory volume in 1 s area under the curve 0 to 1 h after inhalation (FEV1 AUC*0-1 h).
  
  
  METHODS
  A double-blind, double-dummy, multicentre, randomized, placebo controlled, single-dose, five-period crossover study.
  
  
  METHODS
  Five centres in four countries - one centre each in France, Greece and Italy, and two centres in the Netherlands.
  
  
  METHODS
  Forty-seven patients aged 42 to 80 years (mean age 63.5 years) with chronic obstructive pulmonary disease (COPD) stage II and III, and mean baseline FEV1 1.17 L (range 0.56 to 1.77 L).
  
  
  METHODS
  Patients inhaled single doses of formoterol dry powder (12 and 24 mg), single doses of salmeterol (50 and 100 mg) and matching placebo on five separate days.
  
  
  RESULTS
  The estimates of treatment difference in absolute terms (0.086 L) and percentage change from predose baseline (7.8%) for the primary end point, FEV1 AUC*0-1 h, showed that formoterol 12 mg was statistically significantly superior to salmeterol 50 mg (P=0.0044 and P=0.0021, respectively). In addition, both doses of formoterol were statistically superior to placebo for both absolute improvement and percentage change (P=0.0001). The analysis of secondary variables also confirmed the superiority of formoterol over salmeterol.
  
  
  CONCLUSIONS
  Formoterol is associated with a faster onset of bronchodilation than salmeterol in patients with COPD.
authors.affiliation: Novartis Horsham Research Centre, Horsham, United Kingdom. ioannis.kottakis@pharma.novartis.com
authors.forename: John
authors.initials: J
authors.lastname: Kottakis
authors.forename: Giovanni Della
authors.initials: GD
authors.lastname: Cioppa
authors.forename: Jacques
authors.initials: J
authors.lastname: Creemers
authors.forename: Louis
authors.initials: L
authors.lastname: Greefhorst
authors.forename: Violette
authors.initials: V
authors.lastname: Lecler
authors.forename: Riccardo
authors.initials: R
authors.lastname: Pistelli
authors.forename: Tim
authors.initials: T
authors.lastname: Overend
authors.forename: Denise
authors.initials: D
authors.lastname: Till
authors.forename: G nter
authors.initials: Gn
authors.lastname: Rapatz
authors.forename: Vincent
authors.initials: V
authors.lastname: Le Gros
authors.forename: Demosthenes
authors.initials: D
authors.lastname: Bouros
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Siafakas
mesh_terms: D000328:Adult; D000336:Aerosols; D000368:Aged; D000420:Albuterol / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004983:Ethanolamines / Q000627:therapeutic use*; D005260:Female; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D000068299:Salmeterol Xinafoate; D013997:Time Factors
chemical_list: D000336:Aerosols; D001993:Bronchodilator Agents; D004983:Ethanolamines; D000068299:Salmeterol Xinafoate; D000420:Albuterol; D000068759:Formoterol Fumarate