title: Triple therapy with salmeterol/fluticasone propionate 50/250 plus tiotropium bromide improve lung function versus individual treatments in moderate-to-severe Japanese COPD patients: a randomized controlled trial - Evaluation of Airway sGaw after treatment with tripLE.
abstract: OBJECTIVE
  Triple therapy using salmeterol/fluticasone propionate (FP) and tiotropium bromide is commonly used to treat chronic obstructive pulmonary disease (COPD), but sparse efficacy data exist in COPD patients with fewer symptoms and with a lower dose of inhaled corticosteroid in Japanese patients. The effects of of salmeterol/fluticasone propionate 50/250 μg (SFC250) twice daily plus tiotropium 18 μg (TIO) once daily and individual treatments on lung function were compared.
  
  
  METHODS
  Fifty three Japanese COPD patients participated in this randomized, double-blind, double-dummy, Williams square design crossover study. Lung function was assessed by plethysmography and spirometry.
  
  
  RESULTS
  The primary endpoint of postdose specific airway conductance area under the curve (AUC0-4h) on day 28 was significantly higher following SFC250 + TIO (0.854) compared with TIO (0.737, 15.8%) and SFC250 (0.663, 28.8%) alone. SFC250 + TIO significantly improved trough forced expiratory volume in 1 second from baseline versus TIO (0.161 L, P<0.001) and SFC250 (0.103 L, P=0.008). SFC250 + TIO significantly improved residual volume compared with TIO (P<0.001) and SFC250 (P=0.003) on day 28. Nonsignificant improvements were seen in trough inspiratory capacity, total lung capacity, and thoracic gas volume. There was no mean change seen in rescue medication.
  
  
  CONCLUSIONS
  Triple therapy using SFC250 + TIO was well tolerated and gave a greater improvement in bronchodilation compared with TIO and SFC250 alone in Japanese patients with COPD. There was improvement in few symptoms, but no mean change was seen in patient-reported outcomes measured by rescue medication use.
authors.affiliation: Department of Respiratory Medicine, Ibarakihigashi National Hospital, Naka, Ibaraki, Japan.
authors.forename: Takefumi
authors.initials: T
authors.lastname: Saito
authors.affiliation: Center for Pulmonary Medicine, Asahikawa Medical Center, Asahikawa, Hokkaido, Japan.
authors.forename: Akinori
authors.initials: A
authors.lastname: Takeda
authors.affiliation: AMC Nishiumeda Clinic, Osaka, Japan.
authors.forename: Katsuji
authors.initials: K
authors.lastname: Hashimoto
authors.affiliation: Biomedical Science Department, GlaxoSmithKline KK, Tokyo, Japan.
authors.forename: Akihiro
authors.initials: A
authors.lastname: Kobayashi
authors.affiliation: Medical Affairs Respiratory Department, GlaxoSmithKline KK, Tokyo, Japan.
authors.forename: Tomoyuki
authors.initials: T
authors.lastname: Hayamizu
authors.affiliation: Independent Consultant, Marbella, Spain.
authors.forename: Gerald W
authors.initials: GW
authors.lastname: Hagan
mesh_terms: D000280:Administration, Inhalation; D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D000368:Aged; D019540:Area Under Curve; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D018680:Cholinergic Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D000068297:Fluticasone-Salmeterol Drug Combination / Q000008:administration & dosage* / Q000009:adverse effects; D005541:Forced Expiratory Volume; D006801:Humans; D007564:Japan; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D010991:Plethysmography; D011237:Predictive Value of Tests; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D012372:ROC Curve; D020127:Recovery of Function; D012720:Severity of Illness Index; D013147:Spirometry; D013997:Time Factors; D000069447:Tiotropium Bromide / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D014797:Vital Capacity
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D001993:Bronchodilator Agents; D018680:Cholinergic Antagonists; D000068297:Fluticasone-Salmeterol Drug Combination; D000069447:Tiotropium Bromide
keywords: COPD; fluticasone propionate; plethysmography; salmeterol; spirometry; triple therapy