New Data Show Stiolto Respimat Provides Clinically Meaningful Improvements in COPD Health-Related Quality of Life Measure

Boehringer Ingelheim has announced the publication of new data from the Phase IIIb OTEMTO 1&2 trials, which show Stiolto Respimat provided clinically meaningful improvements in SGRQ total score, compared with placebo, in patients with chronic obstructive pulmonary disease (COPD). These data are published online in the journal, Respiratory Medicine.

COPD, which includes chronic bronchitis and emphysema, is a serious but treatable lung disease that can negatively impact a patient's ability to breathe. Along with improving lung function, another major goal of treatment is improving health-related quality of life.

In COPD, health-related quality of life is commonly measured using the SGRQ, a disease-specific patient-reported instrument that evaluates symptoms, activity limitation and the social and emotional impact of the disease. A reduction in SGRQ score represents an improvement, while a reduction of 4 points or more compared with placebo is considered clinically meaningful. In the OTEMTO trials, patients taking Stiolto Respimat reported a reduction in SGRQ total score of 4.67* points compared with 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," said Gary T. Ferguson, Pulmonary Research Institute of Southeast Michigan, Farmington Hills, Michigan, and study investigator. "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 included in an sNDA currently under review by the FDA.

Stiolto Respimat was approved in May 2015 for the long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. Stiolto Respimat is not indicated to treat asthma or acute deterioration of COPD.