Results of Phase II Study of Boehringer Ingelheim?s Investigational Bronchodilator for COPD Presented at 2012 ATS International Conference
Data presented at the 2012 Annual International Conference of the American Thoracic Society (ATS 2012)
San Francisco, CA, May 21, 2012 – Data from a Phase II trial of olodaterol presented today at the 2012 Annual International Conference of the American Thoracic Society (ATS 2012) compared the efficacy of once-daily (QD) versus twice-daily (BID) olodaterol, a long-acting ß2-agonist (LABA) that Boehringer Ingelheim is evaluating as possible maintenance treatment for chronic obstructive pulmonary disease (COPD), delivered via the Respimat® Inhaler. In this Phase II randomized, double-blind, cross-over study, olodaterol administered QD as 5 µg or 10 µg provided a significant and identical increase in the lung function parameter FEV1 over a 24-hour period. This data completes the olodaterol monotherapy Phase II clinical trial program in patients with COPD.
“In this Phase II study, olodaterol administered once daily provided significant bronchodilation over a complete 24-hour period,” said Professor Guy Joos, Head of the Department of Respiratory Diseases at Ghent University Hospital, Belgium, and the coordinating investigator for the trial. “These data are encouraging, and set the stage for olodaterol to be further investigated in Phase III studies in patients with COPD.”
Results of the study found olodaterol 5 µg QD provided significant improvement in lung function as measured by FEV1 AUC0-12 versus twice-daily olodaterol 2 µg, while twice-daily dosing of olodaterol 5 µg had a better FEV1 AUC0-12 profile versus once-daily olodaterol 10 µg. There were no safety or tolerability concerns seen in the study, with no relationship between total daily dose to the overall incidence of adverse events. These results were comparable to previous Phase II studies.
“These trial results and the completion of the olodaterol monotherapy Phase II clinical trial program underscore the Company’s focus on advancing respiratory research and treatment,” said Tunde Otulana, MD, Vice President, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. “We are committed to finding solutions for people living with COPD and are working to develop treatment options that will provide the most benefit for patients.”
Boehringer Ingelheim is currently studying the efficacy and safety of a once-daily fixed-dose combination of tiotropium and olodaterol in the TOviTO Phase III trial program.
Chronic obstructive pulmonary disease (COPD) is also known as chronic bronchitis and emphysema. This disease makes it harder to breathe because less air is able to flow in and out of the lungs. As many as 24 million Americans may have COPD – even those who haven't smoked in years – and half of them remain undiagnosed. COPD is the fourth leading cause of death in the United States. It kills one person every four minutes.
Common symptoms of COPD include coughing with excess mucus or shortness of breath.
Boehringer Ingelheim: Leading respiratory forward
Treatment of respiratory diseases has been a major area of focus for Boehringer Ingelheim for over 90 years and significant resources are dedicated to research in this field. In addition to new possible treatments for asthma, Boehringer Ingelheim has also branched out into developing potential treatment options for other airway diseases, including COPD, lung cancer, idiopathic pulmonary fibrosis and other respiratory diseases.
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. Subsidiary of Boehringer Ingelheim Corporation (Ridgefiled, CT) and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 44,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.
As a central element of its culture, Boehringer Ingelheim pledges to act in a socially responsible manner. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavors.
In 2011, Boehringer Ingelheim achieved net sales of about $17.1 billion (13.2 billion euro). R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.
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Posted: May 2012