Data from Boehringer Ingelheims ANHELTO 1 and ANHELTO 2 studies demonstrate that co-administration of the Spiriva HandiHaler tiotropium DPI and the Striverdi Respimat olodaterol SMI produced significantly greater improvement in the lung function of COPD patients than Spiriva alone. The company presented the data at CHEST 2014.
The 12-week, double-blind studies involved more than 2,200 COPD patients. At the end of the evaluation period, patients using both inhalers showed significant improvements in both trough FEV1 and FEV! area under the curve, 0-3 hours compared to those using Spiriva plus a placebo inhaler. Approximately the same percentage of patients experienced adverse reactions in both groups, with over 40% of patients experiencing an adverse reaction in each group in each study. In almost 11% percent of patients, the COPD worsened.
BI Pharmaceuticals VP, Clinical Development & Medical Affairs, Respiratory, Danny McBryan, said, “We are very encouraged by the data from the ANHELTO studies looking at the co-administration of two of our approved respiratory products, Spiriva HandiHaler and Striverdi Respimat, for the maintenance treatment of COPD. At Boehringer Ingelheim, we’re committed to exploring new treatment approaches so the approximately 15 million Americans who have been told by a healthcare provider that they have COPD can have more options.”
Striverdi Respimat was launched in the US in October 2014 and has been approved in the EU since October 2013. BI submitted an MAA for tiotropium/olodaterol Respimat in the EU in July 2014 and an NDA for the combination Respimat in the US in August 2014
Read the BI press release.
