Boehringer Ingelheim announced new data from a Phase 3b study of Stiolto Respimat (tiotropium, olodaterol) in which treatment with Stiolto Respimat led to significant improvements in SGRQ total score compared to placebo in patients with chronic obstructive pulmonary disease (COPD).
The OTEMTO studies were designed to evaluate the effect of Stiolto Respimat on lung-function improvement and health-related quality of life after 12 weeks of treatment compared to placebo and tiotropium 5mcg in 1,600 patients with moderate to severe COPD. The primary endpoints were SGRQ total score, FEV1 area under the curve from 0–3 hours (AUC0–3) response (change from baseline), and trough FEV1 response (mean of the FEV1 values at 23 hours post-dose and 23 hours and 50 minutes post-dose. Patients in the Stiolto Respimat group reported a reduction in SGRQ total score of 4.67 points at the end of the study compared to those receiving placebo. They also had significant improvements in FEV1, AUC0–3, and trough FEV1 response.
Stiolto Respimat consists of tiotropium bromide, an anticholinergic, and olodaterol, a long-acting beta2-adrenergic agonist (LABA). The Respimat inhaler actively delivers a slow-moving mist that aids the patient independent of inspiratory effort. Data from the OTEMTO studies are included in a supplemental New Drug Application (sNDA) currently under review by the Food and Drug Administration (FDA).
For more information call (800) 542-6257 or visit Stiolto.com.