Boehringer Ingelheim presented data from the 5500-patient, 52-week Phase 3 TONADO studies of tiotropium/olodaterol Respimat for moderate-to-severe COPD at the 2014 ERS International Congress. BI filed an DA for tiotropium/olodaterol Respimat in August 2014.
According to BI, the TONADO studies showed statistically significant improvement in lung function for tiotropium/olodaterol 5/5 mcg compared to tiotropium and olodaterol alone. Improvement in quality of life as measured by the St. George’s Respiratory Questionnaire (SGRQ) was also statistically greater for the fixed dose combination compared to the individual components but was not clinically meaningful, the company said.
BI Pharmaceuticals Senior VP, Clinical Development and Medical Affairs Tunde Otulana said, “The TONADO results, together with the VIVACITO data presented at a major medical meeting earlier this year, formed the basis of the recent regulatory submission to the US Food & Drug Administration for tiotropium + olodaterol FDC delivered via the Respimat inhaler. We’re encouraged by these findings as we continue to investigate additional options for people living with COPD across different severities.”
Read the Boehringer Ingelheim press release.
