Boehringer Ingelheim has presented data from studies of olodaterol and tiotropium at the 2012 Annual Meeting of the American Thoracic Society. According to the company, it has now completed its Phase 2 trials of olodaterol, delivered via the Respimat soft mist inhaler, as a monotherapy for COPD, and that Phase 3 trials are also complete. BI is also developing a fixed dose combination olodaterol/tiotropium Respimat product.
Data presented at ATS show that a once-daily 5 µg dose of olodaterol “demonstrated a significant improvement in FEV1 for at least 24 hours in patients with COPD,” the company said, and that the the 24-hour profile for that dose was superior to a once daily 10 µg dose and to twice daily 2 µg doses.
The co-ordinating investigator for the trial, Guy Joos, Head of the Department of Respiratory Diseases at Ghent University Hospital, Belgium, commented, “In this study, olodaterol was shown to be a true once-daily LABA providing 24-hour bronchodilation in COPD patients. It is promising to see that the strong efficacy results of the Phase 2 program were achieved with the comparably low QD 5µg dose and a favorable safety profile.”
The company also presented data from a Phase 2 study of once-daily tiotropium via the Respimat device in teens with moderate persistent asthma. The 4-week, randomized, double-blind, placebo-controlled, incomplete cross-over dose-ranging study produced data showing that once daily tiotropium dosages of 1.25 µg, 2.5 µg, and 5 µg all increased lung function compared to placebo, with the increase for the 5µg dose being statistically significant.
Lead author Christian Vogelberg of University Children’s Hospital, Dresden, Germany said, “Despite substantial advancements in the treatment of asthma and a wide range of available therapeutic options, a significant number of patients still remain symptomatic. These new results are encouraging because they show that treatment with tiotropium via the Respimat SMI might positively impact lung function despite the fact that all study patients were already receiving usual care maintenance treatment as defined by the GINA guidelines.”
Read the BI press release on the olodaterol study.
Read the BI press release on the tiotropium study.
