Boehringer Ingelheim has published results from the 52-week DYNAGITO study in The Lancet Respiratory Medicine showing that the Stiolto Respimat tiotropium bromide/olodaterol soft mist inhaler produced a 7% greater reduction in moderate-to-severe COPD exacerbations than the Spiriva Respimat tiotropium bromide SMI. According to BI, that reduction was “not reaching the targeted significance level (p=0.01) as pre-defined in the study.”
The study, which involved over 7,800 COPD patients, demonstrated that Stiolto Respimat significantly reduced COPD symptoms and quality of life, the company said.
Stiolto Respimat was approved by the FDA for the treatment of COPD in 2015 and is approved in a number of European countries as Spiolto Respimat.
In 2016, the FDA approved an sNDA for Stiolto Respimat to incorporate data from the OTEMTO 1&2 studies in the label, and BI says that the agency has accepted an sNDA for inclusion of data from the DYNAGITO study in the Stiolto Respimat label.
A co-author of the study, Antonio Anzueto of the University of Texas Health Science Center at San Antonio, commented, “Because exacerbations can cause COPD to progress more quickly, studies such as DYNAGITO are important to understand how medicines can help prevent exacerbations from affecting patients. The findings from the DYNAGITO trial show that Stiolto Respimat provides a clinically important benefit compared to Spiriva Respimat, a well-established treatment approved by the FDA to reduce the risk of COPD exacerbations.”
Read the Boehringer Ingelheim press release.
