Boehringer Ingelheim recently announced the first patient enrollment in their DYNAGITO® trial. DYNAGITO, a 52-week multi-national double-blind trial, is designed to examinee the efficacy of a one-daily of tiotropium + olodaterol Respimat® FDC (5/5 μg) , versus Spiriva Respimat® monotherapy (5 μg), on the exacerbations (risk of symptoms aggravation) of patients with severe COPD.
The trial is part of large study involving 15,000 patients from more than 50 countries called TOviTO® that is testing tiotropium + olodaterol Respimat® FDC.
The DYNAGITO study’s primary endpoint is to determine the annual rate of moderate to severe COPD exacerbation. Secondary endpoints include the time to first moderate-to-severe COPD exacerbation, the annual rate of exacerbation leading to hospitalization, the time to first COPD exacerbations that led to hospitalization, and the time to all-cause mortality. In total, the DYNAGITO trial’s objective is to enroll 7,800 patients in 59 countries. The company is expecting to report the results in 2017.
Currently, Spiriva® is the drug that is most recommended for patients with COPD. Results from clinical trials showed that the drug is effective in reducing the risk of exacerbations, to improve lug function, to improve patients’ quality of life, and to be effective as a long-term prescription for all COPD severities.
However, results from some recent studies revealed that Tiotropium + olodaterol Respimat® FDC compared to tiotropium alone, provided better improvement in lung function, symptom control and health status. At the moment, the drug is waiting approval in Europe and in the US.
“The value of tiotropium in reducing the risk of exacerbations is well known. Data from the TONADO® studies suggest that tiotropium + olodaterol Respimat®may reduce the risk of exacerbations even further than tiotropium alone. We look forward to further evaluating the effect of this potential new treatment on exacerbations in a dedicated exacerbation study,” Professor Peter Calverley added in the press release.