RT Journal Article
SR Electronic
T1 Tiotropium and olodaterol fixed-dose combination <em>versus</em> mono-components in COPD (GOLD 2–4)
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP ERJ-01360-2014
DO 10.1183/09031936.00136014
A1 Roland Buhl
A1 François Maltais
A1 Roger Abrahams
A1 Leif Bjermer
A1 Eric Derom
A1 Gary Ferguson
A1 Matjaž Fležar
A1 Jacques Hébert
A1 Lorcan McGarvey
A1 Emilio Pizzichini
A1 Jim Reid
A1 Antony Veale
A1 Lars Grönke
A1 Alan Hamilton
A1 Lawrence Korducki
A1 Kay Tetzlaff
A1 Stella Waitere-Wijker
A1 Henrik Watz
A1 Eric Bateman
YR 2015
UL http://erj.ersjournals.com/content/early/2015/01/08/09031936.00136014.abstract
AB Efficacy and safety of tiotropium+olodaterol fixed-dose combination (FDC) compared with the mono-components was evaluated in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) in two replicate, randomised, double-blind, parallel-group, multicentre, phase III trials. Patients received tiotropium+olodaterol FDC 2.5/5 μg or 5/5 μg, tiotropium 2.5 μg or 5 μg, or olodaterol 5 μg delivered once-daily via Respimat inhaler over 52 weeks. Primary end points were forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 3 h (AUC0–3) response, trough FEV1 response and St George's Respiratory Questionnaire (SGRQ) total score at 24 weeks. In total, 5162 patients (2624 in Study 1237.5 and 2538 in Study 1237.6) received treatment. Both FDCs significantly improved FEV1 AUC0–3 and trough FEV1 response versus the mono-components in both studies. Statistically significant improvements in SGRQ total score versus the mono-components were only seen for tiotropium+olodaterol FDC 5/5 μg. Incidence of adverse events was comparable between the FDCs and the mono-components. These studies demonstrated significant improvements in lung function and health-related quality of life with once-daily tiotropium+olodaterol FDC versus mono-components over 1 year in patients with moderate to very severe COPD. Lung function and symptomatic benefits of daily tiotropium+olodaterol fixed-dose combination in moderate to very severe COPD http://ow.ly/DIKiY