Background: Two replicate, double-blind, placebo-controlled, 6-week crossover studies assessed the effect of the\nonce-daily long-acting �²2-agonist olodaterol 5 �¼g and 10 �¼g on constant work-rate cycle endurance in patients\nwith moderate to very severe chronic obstructive pulmonary disease.\nMethods: Patients received placebo, olodaterol 5 �¼g once daily (QD) and olodaterol 10 �¼g QD in a randomised\norder for 6 weeks each, with a 2-week washout period in between. The primary end point was change in\nendurance time during constant work-rate cycle ergometry to symptom limitation at 75 % maximal work capacity\nafter 6 weeks of treatment (2 h post-dose), based on log10-transformed data. Key secondary end points were\ninspiratory capacity at isotime and intensity of breathing discomfort at isotime.\nResults: 151 and 157 patients were randomised and treated in Studies 1222.37 and 1222.38, respectively, with 147\nand 154 being included in the full analysis sets. Mean endurance time at week 6 was increased compared to\nplacebo by 14.0 % (Study 1222.37; p < 0.001) and 11.8 % (Study 1222.38; p < 0.01) with olodaterol 5 �¼g, and by\n13.8 % (Study 1222.37; p < 0.001) and 10.5 % (Study 1222.38; p < 0.01) with olodaterol 10 �¼g. Inspiratory capacity at\nisotime increased with olodaterol 5 �¼g (Study 1222.37, 0.182 L, p < 0.0001; Study 1222.38, 0.084 L, p < 0.05) and\n10 �¼g (Study 1222.37, 0.174 L; Study 1222.38, 0.166 L; both studies, p < 0.0001), and breathing discomfort was\nsignificantly reduced in Study 1222.37 (olodaterol 5 �¼g, 0.77 Borg units, p < 0.001; olodaterol 10 �¼g, 0.63 Borg units,\np < 0.01) but not Study 1222.38.\nConclusions: These studies provide further characterisation of the efficacy of olodaterol, showing that\nimprovements in airflow (forced expiratory volume in 1 s) are associated with increases in inspiratory capacity and\nimprovements in exercise endurance time.
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