Respimat Soft Mist Inhaler filed with EU for COPD-Boehringer

Boehringer has submitted Marketing Authorisation Applications in 31 European countries for the once-daily, fixed-dose Respimat Soft Mist Inhaler (tiotropium + olodaterol) as a maintenance bronchodilator treatment for patients with Chronic Obstructive Pulmonary Disease (COPD). The submission is based on efficacy and safety data from the Phase III TOviTO clinical trial programme of more than 8,000 patients.

In addition to evaluating the effects of the tiotropium + olodaterol FDC on lung function, TOviTO is also focused on the evaluation of other outcomes related to the daily life of patients with COPD including quality of life, breathlessness and ability to exercise. In the 6-week VIVACITO study, the first study reported from the TOviTO programme, the tiotropium + olodaterol FDC demonstrated clear and consistent improvements in lung function (FEV1*) over 24 hours compared with tiotropium or olodaterol monotherapies, and placebo. It was shown to have a safety profile similar to its single components.

Data from the pivotal 52-week Phase III TONADO 1&2 trials formed the major part of the regulatory submission. The trials investigated the effect of the tiotropium + olodaterol FDC on lung function and quality of life in patients with moderate to severe COPD. Results from TONADO 1&2 as well as other TOviTO programme data are expected to be reported later in 2014.