During the recent American College of Chest Physicians Annual Meeting (CHEST 2015) in Montreal, Canada, Boehringer Ingelheim Pharmaceuticals, Inc. presented several positive post-hoc analyses from the TONADO® 1&2 and OTEMTO® 1&2 clinical trials.
Phase III TONADO 1&2 (NCT01431274/NCT01431287) and OTEMTO® 1&2 studies evaluated the efficacy and safety of tiotropium/olodaterol delivered via the RESPIMAT inhaler for chronic obstructive pulmonary disease (COPD) in comparison to the individual components (tiotropium and olodaterol delivered by the RESPIMAT inhaler) and placebo in patients with COPD, respectively.
COPD is a term used to designate a group of lung diseases like chronic bronchitis, emphysema and chronic obstructive airways disease. COPD is a common preventable and treatable respiratory condition, although it is a major cause of morbidity and mortality in the world. The first-line treatment for symptoms and airflow obstruction during the exacerbation periods of the condition are short-acting inhaled beta-2 agonists (SABAs) and anticholinergic agents (short-acting muscarinic antagonists, SAMAs).
STIOLTO RESPIMAT was approved last May for the long-term and once a day maintenance therapy for airflow obstruction in patients with COPD, although it is considered not suitable for the treatment of asthma or acute deterioration of COPD.
One analysis showed significant lung function improvement for once a day STIOLTO RESPIMAT among several age groups of adult COPD patients. Additionally, there were two analyses showing that STIOLTO RESPIMAT therapy decreased the frequency of night-time rescue medication usage, as quantified by the number of puffs required per night, and improved the score of Transition Dyspnea Index (TDI, a severity of shortness of breath measurement) in COPD patients compared to tiotropium, olodaterol or placebo alone.
“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,” said Dr. Gary T. Ferguson, Pulmonary Research Institute of Southeast Michigan, Farmington Hills, Michigan, and study investigator, in a press release.
Dr. Ferguson added that these findings together with the additional post-hoc analyses presented at the CHEST 2015 meeting will help to increase the understanding of STIOLTO RESPIMAT’s benefits for COPD patients when compared to tiotropium, olodaterol, and placebo.