Phase III trial shows tiotropium + olodaterol benefit for COPD - Boehringer

Boehringer Ingelheim announced the first Phase III data for the VIVACITO study of once-daily fixed-dose combination of tiotropium and olodaterol which shows that it improved lung function (FEV1*) of COPD patients to levels significantly above those achieved with tiotropium or olodaterol monotherapies, or with placebo. The 6-week trial with an incomplete crossover design was conducted in patients with moderate to severe COPD. In the study, tiotropium + olodaterol FDC was shown to have a safety profile similar to tiotropium.

The results from VIVACITO are the first Phase III data for tiotropium + olodaterol FDC presented from the TOviTO programme, one of the largest Phase III clinical trial programmes ever conducted in COPD. In addition to evaluating the effects of the tiotropium + olodaterol FDC on lung function, the TOviTO programme is also focused on the evaluation of other important clinical outcomes related to the daily life of patients with COPD. The results were presented at the American Thoracic Society (ATS) 2014 International Congress.