Tiotropium and Olodaterol Fixed-dose Combination Versus Mono-components in COPD (GOLD 2-4)

Overview

Journal Eur Respir J

Specialty Pulmonary Medicine

Date 2015 Jan 10

PMID 25573406

Citations 146

Authors

Roland Buhl

Francois Maltais

Roger Abrahams

Leif Bjermer

Eric Derom

Gary Ferguson

Matjaz Flezar

Jacques Hebert

Lorcan McGarvey

Emilio Pizzichini

Jim Reid

Antony Veale

Lars Gronke

Alan Hamilton

Lawrence Korducki

Kay Tetzlaff

Stella Waitere-Wijker

Henrik Watz

Eric Bateman

Affiliations

Soon will be listed here.

Abstract

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.

Citing Articles

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