GlaxoSmithKline recently announced in a press release positive data from two head-to-head trials comparing the safety and efficacy of its product Incruse® Ellipta® (umeclidinium) to two available bronchodilator therapies, tiotropium (trial 201316) and glycopyrronium (trial 201315), as a treatment option for patients with chronic obstructive pulmonary disease (COPD).
According to the press release, data from the study 201316, a 12-week, multicenter and non-U.S. randomized, open-label study involving 1,352 patients, revealed that umeclidinium at a dosage of 62.5 mcg once per day induced, at 12 weeks, a significant improvement in lung function assessed by trough forced expiratory volume in one second (FEV1) in comparison with tiotropium at a dosage of 18 mcg once per day. Based on a per protocol analysis, the observed difference was of 59 ml for umeclidinium in comparison with tiotropium.
Data from study 201315, a 12-week, multicenter, randomized, blinded study involving 1,259 patients revealed that, at the end of the study period, umeclidinium at a dosage of 62.5 mcg once per day was non-inferior to glycopyrronium at a dosage of 44 mcg once per day, a result also determined by trough FEV1 values. The observed difference in this case was of 24 ml for umeclidinium in comparison with glycopyrronium.
In study 201316, for both umeclidinium and tiotropium, the most frequently reported side effects were nasopharyngitis (5% for umeclidinium and 5% for tiotropium) and headache (6% for umeclidinium and 6% for tiotropium). Regarding the overall incidence of side events in study 201316, the rate was of 32% for the group of patients under umeclidinium treatment and of 30% for the group of patients under treatment with tiotropium.
In study 201315, the most frequently on-treatment side events reported for both umeclidinium and glycopyrronium were also nasopharyngitis (8% for umeclidinium and 8% for glycopyrronium) and headache (8% for umeclidinium and 10% for glycopyrronium). In terms of overall incidence of side events in study 201315, the rate was of 37% for the group of patients under treatment with umeclidinium and of 36% for the group of patients under treatment with glycopyrronium.
According to the company’s press release, the results for both of these studies have been posted on the GSK Clinical Study Register and will be presented at a future scientific meeting.