Background:The TORRACTO® study evaluated the effects of tiotropium/olodaterol
versus placebo on endurance time during constant
work-rate cycling and constant speed shuttle walking in patients with
chronic obstructive pulmonary disease (COPD) after 12 weeks of
treatment.Methods:The effects of once-daily tiotropium/olodaterol (2.5/5 and 5/5 μg) on
endurance time during constant work-rate cycle ergometry (CWRCE) after 6 and
12 weeks of treatment were compared with placebo in patients with COPD in a
randomized, double-blind, placebo-controlled, parallel-group clinical trial.
Endurance time during the endurance shuttle walk test (ESWT) after 6 and 12
weeks of treatment was also evaluated in a subset of patients.Results:A total of 404 patients received treatment, with 165 participating in the
ESWT substudy. A statistically significant improvement in endurance time
during CWRCE was observed after 12 weeks (primary endpoint) with
tiotropium/olodaterol 5/5 µg [14% (p = 0.02)] but not with
tiotropium/olodaterol 2.5/5 µg [9% (p = 0.14)]
versus placebo. In the ESWT substudy, a trend to
improvement in endurance time during ESWT after 12 weeks (key secondary
endpoint) was observed with tiotropium/olodaterol 5/5 µg [21%
(p = 0.055)] and tiotropium/olodaterol 2.5/5 µg [21%
(p = 0.056)] versus placebo.Conclusion:Tiotropium/olodaterol 5/5 µg improved endurance time during cycle ergometry
versus placebo, with a strong tendency to also improve
walking endurance time.[ClinicalTrials.gov identifier: NCT01525615.]
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