Boehringer Ingelheim recently announced the completion of the phase IIIb OTEMTO® 1 & 2 trials for their pipeline drug STIOLTO RESPIMAT, and have published the study data online in the Respiratory Medicine journal. The new data reveals that the drug has the potential to improve clinical outcomes in patients with Chronic Obstructive Pulmonary Disorder (COPD) compared to placebo in terms of scores obtained from the St. George’s Respiratory Questionnaire (SGRQ) — an important tool used for mapping improvements in respiratory conditions.
SGRQ is a disease-specific, patient-reported instrument that evaluates symptoms, activity limitation and the social and emotional impact of the disease in the affected — the lower the score on the scale, the higher the level of improvement. When used in clinical trials against a placebo, a reduction of 4 points or more in comparison to the placebo is considered clinically relevant and meaningful. In the OTEMTO trials, the patients recorded a reduction of 4.67 points as compared to the placebo, which led to the conclusion that the drug was successful in improving patient conditions.
OTEMTO® 1 & 2 are part of the >15,000 patient TOviTO® Phase III clinical trial program, one of the largest clinical trial programs conducted in COPD, and data from these studies have been included in an sNDA, currently being reviewed by the FDA.
In May of this year, STIOLTO RESPIMAT was approved for the long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema, but was not indicated to treat asthma or acute deterioration of COPD. Long-acting beta2-adrenergic agonists such as olodaterol — one of the active ingredients in STIOLTO RESPIMAT — are known to increase the risk of asthma-related death, which is why it is not recommended for patients with asthma. STIOLTO RESPIMAT should also not be initiated in acutely deteriorating COPD patients or for the relief of acute symptoms.
“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, MD, 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.”