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Results of Phase II Study of Boehringer Ingelheim's Investigational Bronchodilator for COPD Presented at 2012 ATS International Conference
Date:5/21/2012

SAN FRANCISCO, May 21, 2012 /PRNewswire/ -- 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 beta2-agonist (LABA) that Boehringer Ingelheim is evaluating as a 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 micrograms or 10 micrograms 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 microgram QD provided significant improvement in lung function as measured by FEV1 AUC(0-12) versus twice-daily olodaterol 2 microgram, while twice-daily dosing of olodaterol 5 microgram had a better FEV1 AUC(0-12) profile versus once-daily olodaterol 10 microgram.  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,"
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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