title: Efficacy of fluticasone propionate/formoterol fumarate in the treatment of asthma: a pooled analysis.
abstract: BACKGROUND
  Fluticasone propionate and formoterol fumarate have been combined in a single inhaler (fluticasone/formoterol; flutiform(®)) for the maintenance treatment of asthma. This pooled analysis assessed the efficacy of fluticasone/formoterol versus fluticasone in patients who previously received inhaled corticosteroids.
  
  
  METHODS
  Data were pooled from five randomised studies in patients with asthma (aged ≥12 years) treated for 8 or 12 weeks with fluticasone/formoterol (100/10, 250/10 or 500/20 μg b.i.d.; n = 528 delivered via pMDI) or fluticasone alone (100, 250 or 500 μg b.i.d.; n = 527).
  
  
  RESULTS
  Fluticasone/formoterol provided significantly greater increases than fluticasone alone in mean morning forced expiratory volume in 1 second (FEV1) from pre-dose at baseline to 2 hours post-dose at study end (least-squares mean [LSM] treatment difference: 0.146L; p < 0.001) and in pre-dose FEV1 from baseline to study end (LSM treatment difference: 0.048 L; p = 0.043). Compared with fluticasone, fluticasone/formoterol provided greater increases in the percentage of asthma control days (no symptoms, no rescue medication use and no sleep disturbance due to asthma) from baseline to study end (LSM treatment difference: 8.6%; p < 0.001), and was associated with a lower annualised rate of exacerbations (rate ratio: 0.71; p = 0.014).
  
  
  CONCLUSIONS
  In summary, fluticasone/formoterol provides clinically significant improvements in lung function and asthma control measures, with a lower incidence of exacerbations than fluticasone alone.
authors.affiliation: Department of Clinical and Experimental Medicine, University of Ferrara, Ferrara, Italy. Electronic address: ppa@unife.it.
authors.forename: Alberto
authors.initials: A
authors.lastname: Papi
authors.affiliation: Centre of Academic Primary Care, University of Aberdeen, Aberdeen, UK. Electronic address: david@respiratoryresearch.org.
authors.forename: David
authors.initials: D
authors.lastname: Price
authors.affiliation: Fundacion Jimenez Diaz and CIBERES, Madrid, Spain. Electronic address: JSastre@fjd.es.
authors.forename: Joaquin
authors.initials: J
authors.lastname: Sastre
authors.affiliation: Skyepharma, Muttenz, Switzerland. Electronic address: K.Kaiser@skyepharma.com.
authors.forename: Kirsten
authors.initials: K
authors.lastname: Kaiser
authors.affiliation: Mundipharma Research Limited, Cambridge, UK. Electronic address: Mark.Lomax@mundipharma-rd.eu.
authors.forename: Mark
authors.initials: M
authors.lastname: Lomax
authors.affiliation: Mundipharma Research Limited, Cambridge, UK. Electronic address: Tammy.McIver@mundipharma-rd.eu.
authors.forename: Tammy
authors.initials: T
authors.lastname: McIver
authors.affiliation: Mundipharma Research Limited, Cambridge, UK. Electronic address: Sanjeeva.Dissanayake@mundipharma-rd.eu.
authors.forename: Sanjeeva
authors.initials: S
authors.lastname: Dissanayake
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D000068298:Fluticasone / Q000008:administration & dosage*; D005541:Forced Expiratory Volume / Q000187:drug effects; D000068759:Formoterol Fumarate / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001993:Bronchodilator Agents; D000068298:Fluticasone; D000068759:Formoterol Fumarate
keywords: Asthma; Combination therapy; Efficacy; Fluticasone propionate; Formoterol fumarate