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ETHOS: Fixed triple-combination therapy reduces COPD exacerbations
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New data from the ETHOS trial showed that triple-combination therapy with budesonide, glycopyrronium and formoterol at two different budesonide doses reduced exacerbations in patients with moderate to very severe COPD, according to a manufacturer press release.
In the trial, investigators compared the triple-combination therapy PT010 — budesonide/glycopyrronium/formoterol — with two dual-combination therapies that are currently recommended therapeutic classes for treatment of COPD, including PT009 (budesonide 320 µg/formoterol 9.6 µg) and glycopyrronium 14.4 µg/formoterol fumarate 9.6 µg. All treatments were administered in pressurized metered-dose inhaler using Aerosphere Delivery Technology.
Compared with the dual therapies, PT010 at the standard budesonide dose (320 µg/glycopyrronium 14.4 µg/formoterol 9.6 µg) was associated with a statistically significant reduction in the rate of moderate or severe exacerbations. Similar results were also observed comparing PT010 at half the budesonide dose (budesonide 160 µg/glycopyrronium 14.4 µg/formoterol 9.6 µg) with the dual-combination therapies. Safety and tolerability of PT010 were also consistent with the known profiles of the dual-combination comparators, according to the release.
“The phase 3 ETHOS trial results are exciting and demonstrate that PT010 significantly reduces the rate of exacerbations. This is also the first time we have seen the benefit of fixed-dose triple-combination therapy at two inhaled corticosteroid doses, which could transform treatment practice by allowing physicians to select the optimal dose for individual patients,” Klaus Rabe, MD, PhD, professor of pulmonary medicine at the University of Kiel; director of the department of pneumology at Clinic Grosshandorf, Germany; and lead investigator of the ETHOS trial, said in the release.
ETHOS is a randomized, double-blind, multicenter, parallel-group, 52-week trial to assess safety and efficacy of PT010 in symptomatic patients with moderate to very severe COPD and a history of exacerbations in the previous year. The primary endpoint was the rate of moderate or severe exacerbations. The full results from the study, which build on data from the phase 3 KRONOS trial, will be presented at an upcoming medical meeting, the manufacturer stated in the release.
Currently, PT010 is approved in Japan and is under regulatory review in China, where it has been granted priority review by the National Medical Products Administration. It is also under regulatory review in the U.S. and European Union.