Date: 2012-05-21
Type of information:
phase: 2
Announcement: presentation of phase 2 results at the 2012 Annual International Conference of the American Thoracic Society (ATS 2012)
Company: Boehringer Ingelheim (Germany)
Product: olodaterol
Action mechanism: Olodaterol is a long-acting beta2-agonist (LABA).
Disease: chronic obstructive pulmonary disease (COPD)
Therapeutic area: Respiratory diseases
Country:
Trial details:
Latest
news: Data from a Phase II trial of olodaterol have been presented at the 2012 Annual International Conference of the American Thoracic Society (ATS 2012). The study 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. 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. 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.
