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ARTICLE | Clinical News

Spiriva HandiHaler tiotropium: Phase IV data

September 10, 2012 7:00 AM UTC

A double-blind, U.S. and Canadian Phase IV trial (205.440) in 126 patients with mild to moderate COPD showed that once-daily 18 µg Spiriva HandiHaler tiopropium significantly improved mean isotime inspiratory capacity, the primary endpoint, from baseline to week 6 during rest (125 mL, p<0.0001) and exercise (65 mL, p=0.009) compared to placebo. Spiriva did not significantly improve the secondary endpoint of exercise duration from baseline to week 6 vs. placebo in the overall trial population or in a subgroup of patients with mild COPD, but did significantly improve exercise duration from baseline to week 6 by 63 seconds vs. placebo in a subgroup of patients with moderate COPD (p=0.007). The trial enrolled current or former smokers >=40 years old with a post-bronchodilator forced expiratory volume in 1 second (FEV1) of <70% and a >=50% predicted airflow limitation who performed constant work rate exercise on a treadmill at 80% of peak incremental test work rate before and after treatment periods. Data were presented at the European Respiratory Society meeting in Vienna. ...