Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., part of Boehringer Ingelheim GmbH, presented data from the ANHELTO 1&2 studies (NCT01694771/NCT01696058) that evaluated the co-administration of Spiriva Handihaler (tiotropium bromide inhalation powder) plus Striverdi Respimat (olodaterol) Inhalation Spray inhaler in 2,200 patients with chronic obstructive pulmonary disease (COPD) at the American College of Chest Physicians (ACCP) 80th annual meeting in Austin, Texas. At week 12, patients receiving T+O showed significant improvements in lung function, as measured by trough forced expiratory volume in one second (FEV1) and FEV1 area under the curve from 0-3 hours (FEV1AUC0-3h), compared to patients receiving tiotropium + placebo (T+P). The primary efficacy endpoints were change from baseline in trough FEV1 and FEV1AUC0-3 after 12 weeks.
Sunovion Pharmaceuticals Inc., of Marlborough, Mass., reported dose-ranging results from a phase II, randomized, double-blind, placebo-controlled, parallel group study of SUN-101 (glycopyrrolate inhalation solution) delivered via the innovative, proprietary Eflow nebulizer system twice a day in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). All four doses (12.5 mcg, 25 mcg, 50 mcg and 100 mcg) studied produced statistically and clinically significant changes in forced expiratory volume in one second (trough FEV1) in bronchodilation, which persisted throughout the 24-hour dosing interval to inform dose selection. Data were presented at the 2014 American College of Chest Physicians annual meeting in Austin. The primary endpoint of the study was change from baseline in morning trough FEV1 after 28 days of treatment.