title: Comparable efficacy and tolerability of formoterol (Foradil) administered via a novel multi-dose dry powder inhaler (Certihaler) or the Aerolizer dry powder inhaler in patients with persistent asthma.
abstract: BACKGROUND
  For maximum treatment compliance there is a need to provide asthma patients with devices that suit their particular preferences. The Foradil Certihaler is a novel multi-dose dry powder inhaler developed to increase the choice of devices available.
  
  
  OBJECTIVE
  To evaluate the safety and efficacy of formoterol administered via the Foradil Certihaler, or via the single-dose inhaler Foradil Aerolizer.
  
  
  METHODS
  This was a randomized, placebo-controlled, double-dummy, incomplete block crossover, dose-ranging and pharmacokinetic study in patients with persistent asthma. Sixty-seven patients (mean 48.0 years) were randomized to formoterol 5, 10, 15 and 30 microg twice daily via the Certihaler, 12 microg formoterol b.i.d. via the Aerolizer, or placebo in four 1-week double-blind treatment periods separated by 1-week single-blind washouts. RESULTS All formoterol doses delivered via the Certihaler or the Aerolizer significantly increased FEV(1) compared with placebo (p < 0.0001). Formoterol demonstrated an onset of action of <3 min. All active treatments were well tolerated. Tremor was the most common adverse event and was more pronounced at high doses. At lower doses the incidence of tremor with the Certihaler was similar to that observed with placebo or the Aerolizer. The pharmacokinetic evaluation comprised 41 patients (mean 45.9 years). Urinary excretion of unchanged formoterol and total formoterol increased with dose delivered via the Certihaler. The optimum dose of formoterol via the Certihaler was 10 microg.
  
  
  CONCLUSIONS
  Delivery of formoterol via the Certihaler or Aerolizer combines rapid relief with enduring control and provides convenient bronchodilation in patients with persistent asthma.
authors.affiliation: Aarhus Kommunehospital, Aarhus, Denmark.
authors.forename: R
authors.initials: R
authors.lastname: Dahl
authors.forename: J P
authors.initials: JP
authors.lastname: Creemers
authors.forename: J
authors.initials: J
authors.lastname: Van Noord
authors.forename: A
authors.initials: A
authors.lastname: Sips
authors.forename: G
authors.initials: G
authors.lastname: Della Cioppa
authors.forename: M
authors.initials: M
authors.lastname: Thomson
authors.forename: K
authors.initials: K
authors.lastname: Andriano
authors.forename: J
authors.initials: J
authors.lastname: Kottakis
authors.forename: T
authors.initials: T
authors.lastname: Fashola
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D019540:Area Under Curve; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000652:urine; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004983:Ethanolamines / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000652:urine; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D011208:Powders; D012141:Respiratory Tract Infections / Q000139:chemically induced; D016896:Treatment Outcome; D014202:Tremor / Q000139:chemically induced
chemical_list: D001993:Bronchodilator Agents; D004983:Ethanolamines; D011208:Powders; D000068759:Formoterol Fumarate