title: Efficacy and safety of fluticasone/formoterol combination therapy in patients with moderate-to-severe asthma.
abstract: BACKGROUND
  The inhaled corticosteroid, fluticasone propionate, and the long-acting β(2)-adrenergic agonist, formoterol fumarate, are both highly effective treatments for bronchial asthma. This study (NCT00393952/EudraCT number: 2006-005989-39) compared the efficacy and safety of fluticasone/formoterol combination therapy (flutiform(®); 250/10 μg) administered twice daily (b.i.d.) via a single aerosol inhaler, with the individual components (fluticasone 250 μg b.i.d.; formoterol 10 μg b.i.d.), in adult and adolescent patients with moderate-to-severe asthma.
  
  
  METHODS
  This was a 12-week, double-blind, randomised, parallel-group, multicentre, placebocontrolled phase 3 study. The co-primary efficacy endpoints were: i) the mean change in the forced expiratory volume in the first second (FEV(1)) from morning pre-dose at baseline to pre-dose at week 12 (fluticasone/formoterol 250/10 μg vs. formoterol), ii) the mean change in FEV(1) from morning pre-dose at baseline to 2 h post-dose at week 12 (fluticasone/formoterol 250/10 μg vs. fluticasone), and iii) the number of patients who discontinued prematurely due to lack of treatment efficacy (fluticasone/formoterol 250/10 μg vs. placebo). The secondary endpoints included measures of lung function, disease control, and asthma symptoms. Safety was assessed based on adverse events, vital signs, and clinical laboratory evaluations.
  
  
  RESULTS
  Overall, 395 (70.9%) patients completed the study. Fluticasone/formoterol 250/10 μg b.i.d. was superior to the individual components and placebo for all three co-primary endpoints and demonstrated numerically greater improvements for multiple secondary efficacy analyses. Fluticasone/formoterol combination therapy had a good safety profile over the 12 weeks.
  
  
  CONCLUSIONS
  Fluticasone/formoterol combination therapy will provide clinicians with an efficacious alternative treatment option for patients with moderate-to-severe asthma.
authors.affiliation: Allergy Medical Clinic, 10780 Santa Monica Blvd., Suite 280, Los Angeles, CA 90025, USA. jcorren@ucla.edu
authors.forename: Jonathan
authors.initials: J
authors.lastname: Corren
authors.forename: Lyndon E
authors.initials: LE
authors.lastname: Mansfield
authors.forename: Tetyana
authors.initials: T
authors.lastname: Pertseva
authors.forename: Viktor
authors.initials: V
authors.lastname: Blahzko
authors.forename: Kirsten
authors.initials: K
authors.lastname: Kaiser
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004983:Ethanolamines / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D000068298:Fluticasone; D005541:Forced Expiratory Volume / Q000187:drug effects; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D036501:Metered Dose Inhalers; D008875:Middle Aged; D017211:Treatment Failure; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D000730:Androstadienes; D001993:Bronchodilator Agents; D004338:Drug Combinations; D004983:Ethanolamines; D000068298:Fluticasone; D000068759:Formoterol Fumarate