The DYNAGITO study will assess the potential benefit of Tiotropium plus Olodaterol Respimat FDC ( fixed-dose combination ) compared to Spiriva ( Tiotropium ) Respimat on reducing the risk of sudden worsening of symptoms (e xacerbations ) and improving survival in patients with COPD.
The 52-week study aims to involve 7,800 patients in 59 countries.

Chronic obstructive pulmonary disease, known as COPD, is a serious but treatable lung disease affecting 65 million patients worldwide. COPD patients suffer from breathlessness which affects their ability to live their lives to the full from very early on in the disease. Sudden worsening of symptoms can occur unexpectedly in patients and can be serious and life-threatening.
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.

Spiriva is the most prescribed COPD maintenance therapy worldwide. 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.
Tiotropium plus 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.

DYNAGITO is a 52-week multi-national double-blind trial designed to investigate the impact of once daily, orally inhaled Tiotropium plus Olodaterol Respimat FDC ( 5/5 mcg ) compared to Spiriva Respimat monotherapy ( 5 mcg ) on exacerbations in patients with severe to very severe COPD.
The primary endpoint of the trial is annualised rate of moderate to severe COPD exacerbation. Additional endpoints include time to first moderate to severe COPD exacerbation, annualised rate of exacerbation leading to hospitalisation, time to first COPD exacerbations leading to hospitalisation and time to all-cause mortality. ( Xagena )

Source: Boehringer Ingelheim, 2015

XagenaMedicine2015