title: Assessment of the efficacy and safety of fluticasone propionate and salmeterol delivered as a combination dry powder via a capsule-based inhaler versus a multi-dose inhaler in patients with chronic obstructive pulmonary disease.
abstract: This study tested the clinical non-inferiority of the fluticasone propionate/salmeterol combination 50/250 μg (FSC) Rotacaps®/Rotahaler®system, a single unit dose inhaler, with the multi-dose FSC Diskus®inhaler in adults with chronic obstructive pulmonary disease (COPD).
  
  
  
  This multi-centre, randomised, double-blind, double-dummy, two-way cross-over study compared 12 weeks' treatment of FSC administered twice daily using Rotacaps/Rotahaler or Diskus. The primary endpoint was change from baseline in trough morning forced expiratory volume in 1 s (FEV1) at Day 85, and the pre-defined non-inferiority criteria was: the lower limit of the confidence interval (CI) for the treatment difference (Rotacaps/Rotahaler-Diskus) in least squares (LS) mean change from baseline, being greater than -45 mL. Secondary endpoints included change in breathlessness (as measured by transition dyspnoea index (TDI)) and COPD-specific health status measures.
  
  
  
  The LS mean increase from baseline in trough FEV1at Day 85 was 116 mL in the Rotacaps/Rotahaler group and 91 mL in the Diskus group (difference in model-adjusted LS mean change: 25 mL (95% CI 2 mL, 47 mL)), the lower limit of the CI for the treatment difference being greater than the protocol-defined criterion for non-inferiority i.e. -45 mL. Data for breathlessness, COPD-specific health status and safety parameters were similar following FSC treatment via either inhaler.
  
  
  
  This study demonstrated the clinical non-inferiority of FSC 50/250 μg when administered using Rotacaps/Rotahaler compared with Diskus in patients with COPD. The risk:benefit profile for the two inhalers was comparable.
authors.affiliation: GlaxoSmithKline, Stockley Park, Uxbridge, UK. Electronic address: robert.h.chan@gsk.com.
authors.forename: Robert
authors.initials: R
authors.lastname: Chan
authors.affiliation: GlaxoSmithKline, Stockley Park, Uxbridge, UK.
authors.forename: Ana R
authors.initials: AR
authors.lastname: Sousa
authors.affiliation: GlaxoSmithKline, Stockley Park, Uxbridge, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Hynds
authors.affiliation: GlaxoSmithKline, Stockley Park, Uxbridge, UK.
authors.forename: Farshid
authors.initials: F
authors.lastname: Homayoun-Valiani
authors.affiliation: GlaxoSmithKline, Stockley Park, Uxbridge, UK.
authors.forename: Dawn
authors.initials: D
authors.lastname: Edwards
authors.affiliation: GlaxoSmithKline, Stockley Park, Uxbridge, UK.
authors.forename: Maggie
authors.initials: M
authors.lastname: Tabberer
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D000068297:Fluticasone-Salmeterol Drug Combination / Q000008:administration & dosage* / Q000009:adverse effects; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000503:physiopathology
chemical_list: D001993:Bronchodilator Agents; D000068297:Fluticasone-Salmeterol Drug Combination
keywords: Asthma; Fluticasone propionate; Multi-dose inhaler; Non-inferiority; Salmeterol; Unit-dose inhaler