Boehringer Ingelheim has presented new data from several Phase 3 studies of olodaterol for the treatment of COPD and from the TIOSPIR tiotropium Respimat study at the European Respiratory Society (ERS) Annual Congress 2013. Data from the olodaterol studies shows that two tested doses of the drug delivered by the Respimat inhaler improved lung function in COPD patients. The TIOSPIR study, as reported recently in the New England Journal of Medicine, showed comparable safety profiles for tiotropium Respimat and for tiotropium HandiHaler.
One set of olodaterol studies showed statistically significant difference in FEV1 for once daily olodaterol at doses of 5 and 10 µg compared to placebo pluse usual care. Another set of studies showed comparable improvement in lung function for both doses of olodaterol compared to twice daily 12 µg doses of formoterol. Patients also used less rescue medication when using olodaterol and formoterol versus placebo.
Data from the TIOSPIR (Tiotropium Safety and Performance in Respimat) study presented at ERS shows non-inferiority of tiotropium delivered by the Respimat soft mist inhaler compared to tiotropium delivered by the HandiHaler DPI on mortality.
BI Pharmaceuticals Senior VP, Clinical Development and Medical Affairs Tunde Otulana commented, “These are very exciting data as they provide extensive information on the safety of tiotropium delivered via the Respimat inhaler. The findings of the TIOSPIR study strongly support our pursuit of approval for tiotropium Respimat in the United State, and provide Boehringer Ingelheim with the confidence to continue studying this innovative delivery system with other investigational respiratory therapies in our portfolio.”
Read the BI press release on olodaterol.
Read the BI press release on tiotropium.
