title: Efficacy and safety of fluticasone and formoterol in a single pressurized metered dose inhaler.
abstract: BACKGROUND
  Fluticasone and formoterol are well established medications for the treatment of asthma. This study (Clinicaltrials.gov identifier: NCT00734318) compares the efficacy and safety of a combination of these drugs in a single inhaler (fluticasone/formoterol) versus the individual components (fluticasone + formoterol).
  
  
  METHODS
  Patients aged ≥ 18 years (n=620) with a history of severe, persistent reversible asthma for ≥ 6 months prior to screening were included in this randomized, double-blind study, which consisted of a screening phase of up to 5 days, a 2-week run-in phase and an 8-week treatment period.
  
  
  RESULTS
  Fluticasone/formoterol (500/20 μg, b.i.d.) was at least as effective as fluticasone + formoterol (500 μg + 24 μg, b.i.d.) with respect to the primary outcome measure: there were similar increases in mean pre-morning dose forced expiratory volume in the first second (FEV(1)) in these two groups. Fluticasone/formoterol (500/20 μg, b.i.d.) also demonstrated similar efficacy to fluticasone + formoterol in terms of change in mean FEV(1) from baseline pre-morning dose to 2 h post-morning dose at week 8, as well as for several secondary parameters. Fluticasone/formoterol (500/20 μg, b.i.d.) demonstrated superiority to fluticasone monotherapy (500 μg, b.i.d.) and fluticasone/formoterol (100/10 μg, b.i.d.) for several secondary efficacy parameters. Fluticasone/formoterol had a similar safety and tolerability profile to fluticasone + formoterol.
  
  
  CONCLUSIONS
  This study demonstrated that the fluticasone/formoterol combination is at least as effective as its components administered concurrently from separate inhalers. Fluticasone/formoterol (500/20 μg, b.i.d.) showed superior efficacy to its inhaled corticosteroid component alone and the efficacy of fluticasone/formoterol was dose-dependent for several clinically important parameters.
authors.affiliation: Department of Allergology and Internal Medicine, Medical University of Białystok, M.Sklodowskiej-Curie 24 A, 15-276 Bialystok, Poland. abodzentalukaszyk@gmail.com
authors.forename: Anna
authors.initials: A
authors.lastname: Bodzenta-Lukaszyk
authors.forename: Grażyna
authors.initials: G
authors.lastname: Pulka
authors.forename: Andrzej
authors.initials: A
authors.lastname: Dymek
authors.forename: Dragos
authors.initials: D
authors.lastname: Bumbacea
authors.forename: Tammy
authors.initials: T
authors.lastname: McIver
authors.forename: Birgit
authors.initials: B
authors.lastname: Schwab
authors.forename: Heikki
authors.initials: H
authors.lastname: Mansikka
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000730:Androstadienes / Q000008:administration & dosage*; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D004812:Epidemiologic Methods; D004983:Ethanolamines / Q000008:administration & dosage*; D005260:Female; D000068298:Fluticasone; D005541:Forced Expiratory Volume / Q000187:drug effects* / Q000502:physiology; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D036501:Metered Dose Inhalers; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D004338:Drug Combinations; D004983:Ethanolamines; D000068298:Fluticasone; D000068759:Formoterol Fumarate