New trial data: Boehringer Ingelheim’s Stiolto Respimat improving quality of life

RIDGEFIELD, Conn. — Boehringer Ingelheim earlier this week released new data from its clinical trials for its Phase IIIb OTEMTO 1&2 trials, which indicate that Stiolto Respimat provided provided “clinically meaningful improvements” in the St. George’s Respiratory Questionnaire (SGRQ) total score, compared to placebo, in patients with chronic obstructive pulmonary disease, the company said. 

The SGRQ is a patient-reported instrument that evaluates symptoms, activity limitation and the social and emotional impact of chronic obstructive pulmonary disease. A reduction in SGRQ score represents an improvement, while a reduction of four points or more, compared to placebo, is considered “clinically meaningful,” the company said.  In the OTEMTO trials, patients taking Stiolto Respimat reported a reduction in SGRQ total score of 4.67 points, compared to placebo.

“In the recent publication of the OTEMTO trials, Stiolto Respimat improved the SGRQ scores by more than 4 points which is considered the minimum clinically important difference for this measure of health-related quality of life among COPD patients,” study investigator Dr. Gary T. Ferguson said. “These data add to the growing body of evidence for Stiolto Respimat, which has been clinically proven to significantly improve lung function compared to tiotropium respimat, olodaterol respimat and placebo, with a similar safety profile.”

Data from the OTEMTO studies are currently under review by the FDA.