Post-hoc analysis of the TONADO and OTEMTO trials of the 15,000-patient phase III Chronic Obstructive Pulmonary Disease (COPD) clinical trial TOviTO assessing Boehringer Ingelheim‘s STIOLTO RESPIMAT’s efficacy and safety in COPD were recently presented at the American College of Chest Physicians Annual Meeting (CHEST 2015) in Montreal, Canada.
Results showed that in comparison with tiotropium, olodaterol or placebo alone, a daily dose of STIOLTO RESPIMAT significantly improves lung function, decreases episodes of shortness of breath, and reduces the need for nighttime rescue medication in COPD patients from a wide range of age groups (adults less than 65 years, 65 to 74 years, 75 to 84 years and 85 or more years).
Dr. Gary T. Ferguson, from the Pulmonary Research Institute of Southeast Michigan and a study researcher, stated in a press release: “The results from these pre-planned subgroup analyses of the TONADO® 1&2 and OTEMTO® 1&2 studies provide additional insights into STIOLTO RESPIMAT as an effective treatment option for adult COPD patients across a range of ages, who are most commonly taking a maintenance medicine. These data, along with the additional post-hoc analyses presented at the meeting, add to our understanding of STIOLTO RESPIMAT’s benefits to COPD patients compared to tiotropium, olodaterol, and placebo.”
STIOLTO RESPIMAT was approved in May as a long-term, once-daily maintenance treatment for airflow obstruction in COPD, namely chronic bronchitis and/or emphysema. The inhalation spray commercialized by Boehringer Ingelheim Pharmaceuticals, Inc., is a combination of tiotropium and olodaterol, which are long-acting anticholinergic and beta2-adrenergic agonist bronchodilators. Adverse effects of STIOLTO RESPIMAT are similar and have the same persistence to those of long-acting bronchodilators, namely cough, nasopharyngitis (common cold) and back pain. Boehringer Ingelheim notes that the therapy should not be used for relief of acute COPD symptoms, in COPD patients with acutely deteriorating COPD, or in asthma patients, since beta2-adrenergic agonists increase the risk of asthma-related death.
Regarding this recently approved COPD therapy, Dr. Danny McBryan, vice president of the Respiratory Clinical Development & Medical Affairs of Boehringer Ingelheim, added, “As a leader in COPD care for more than 40 years in the U.S., we’re encouraged by these data as we continue to explore the potential benefits of STIOLTO RESPIMAT for COPD patients.”