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

Takefumi Saito,1 Akinori Takeda,2 Katsuji Hashimoto,3 Akihiro Kobayashi,4 Tomoyuki Hayamizu,5 Gerald W Hagan6 1Department of Respiratory Medicine, Ibarakihigashi National Hospital, Naka, Ibaraki, 2Center for Pulmonary Medicine, Asahikawa Medical Center, Asahikawa, Hokkaido, 3AMC Nishiumeda Clinic, Osaka, 4Biomedical Science Department, 5Medical Affairs Respiratory Department, GlaxoSmithKline KK, Tokyo, Japan; 6Independent Consultant, Marbella, Spain Purpose: 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. Patients and 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. Conclusion: 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. Keywords: COPD, fluticasone propionate, plethysmography, salmeterol, spirometry, triple therap