Boehringer Ingelheim has started patient enrolment in its large-scale Dynagito study to treat chronic obstructive pulmonary disease (COPD).
The trial is designed to evaluate 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 these patients.
Spiriva is the most prescribed COPD maintenance therapy across the world and its position 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.
University of Liverpool professor of Pulmonary and Rehabilitation Medicine and lead study investigator Peter Calverley said: "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."
Around 7,800 patients in 59 countries will be enrolled in the 52-week multi-national double-blind trial.
The trial will investigate the impact of once daily, orally inhaled tiotropium + olodaterol Respimat FDC (5/5µg) compared to Spiriva Respimat monotherapy (5µg) on exacerbations in patients with severe to very severe COPD.
Calverley noted: "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."
According to the company, results from the trial are expected to be reported in 2017.
The Dynagito trial is part of the TOviTO clinical trial programme for tiotropium + olodaterol Respimat FDC.
Image: Boehringer Ingelheim's corporate headquarters in Ingelheim, Germany. Photo: courtesy of Boehringer Ingelheim GmbH.