INGELHEIM, Germany--(BUSINESS WIRE)--For media outside the US, the UK and Canada
Boehringer Ingelheim today announced that the first patient has been enrolled into its large-scale DYNAGITO® study.1 It will assess the potential benefit of tiotropium + olodaterol Respimat® FDC† compared to Spiriva® (tiotropium) Respimat®‡ on reducing the risk of sudden worsening of symptoms (exacerbations) and improving survival in patients with COPD. The 52-week study aims to involve 7,800 patients in 59 countries. Results are expected in 2017.
Chronic obstructive pulmonary disease, known as COPD, is a serious but treatable lung disease affecting 65 million patients worldwide.3 COPD patients suffer from breathlessness which affects their ability to live their lives to the full from very early on in the disease.4 Sudden worsening of symptoms can occur unexpectedly in patients and can be serious and life-threatening.5
Lead study investigator Peter Calverley, Professor of Pulmonary and Rehabilitation Medicine, University of Liverpool, UK commented, “Exacerbations not only worsen the lung function of COPD patients and often lead to hospitalisation, they also have a significant impact on patients’ overall wellbeing. In severe cases, exacerbations even increase the risk of death. Therefore, there is an ongoing need to optimise the effect of treatment in reducing the risk of exacerbations in COPD.”
Spiriva® is the most prescribed COPD maintenance therapy worldwide.6 The leading position of Spiriva® is supported by proven clinical efficacy in reducing the risk of COPD exacerbations and improving lung function, improving quality of life in COPD patients and positive long term experience across all COPD severities.7-13 Tiotropium + olodaterol Respimat® FDC is a potential new treatment option which builds on the long term experience of Spiriva®, showing, compared to tiotropium alone, greater improvement in lung function, symptom control and health status in patients with COPD.14 It was submitted for marketing authorisation in Europe and the US in 2014.
“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.
DYNAGITO® is part of the extensive TOviTO® clinical trial programme for tiotropium + olodaterol Respimat® FDC. TOviTO®, which also encompasses the already reported TONADO®,14 VIVACITO®,15 and TORRACTO®16 studies, includes 12 clinical trials in total. Once DYNAGITO® is completed, TOviTO® will involve over 15,000 patients in more than 50 countries.
* Tiotropium + olodaterol Respimat® FDC
(fixed-dose combination) is an investigational treatment. Its safety and
efficacy have not yet been fully established
† The dose of tiotropium + olodaterol Respimat® FDC in the trial is 5/5 μg
‡ The dose of Spiriva® Respimat® in the trial is 5 μg
For ‘Notes to Editors’ and ‘References’ please visit: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/27_january_2015_copd.html