AstraZeneca announced positive results from the phase 3 ETHOS trial of PT010 for patients with moderate to very severe chronic obstructive pulmonary disease (COPD).

PT010 is a single inhaler, fixed-dose triple-combination therapy of budesonide, an inhaled corticosteroid (ICS) with glycopyrronium, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta2-agonist (LABA). The treatment is delivered via a pressurized metered-dose inhaler utilizing AstraZeneca’s AEROSPHERE Delivery Technology.

The ETHOS trial was a double-blind, multicenter, parallel-group, 52-week study that evaluated the efficacy and safety of PT010 compared with PT003 (glycopyrronium/formoterol 14.4/9.6mcg) and PT009 (budesonide/formoterol fumarate 320/9.6mcg) on COPD exacerbations in patients with moderate to very severe COPD (N=8572). Patients were randomized to receive PT010 320/14.4/9.6mcg or 160/14.4/9.6mcg, PT009 320/9.6mcg, or PT003 14.4/9.6mcg. The primary end point was the rate of moderate or severe COPD exacerbations.

Results demonstrated a statistically significant reduction in the rate of moderate or severe exacerbations at both doses of PT010 compared with PT003 and PT009 dual-combination therapies. Findings from the study revealed a safety profile similar to that seen with the dual-combination therapies; full detailed data will be presented at an upcoming medical meeting.

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Klaus Rabe, Professor of Pulmonary Medicine at the University of Kiel, Director of the Department of Pneumology at Clinic Grosshansdorf, Germany, and lead investigator of the ETHOS trial, said: “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.”

The ETHOS trial is part of AstraZeneca’s clinical program for PT010, which also includes the KRONOS, TELOS, and SOPHOS studies.

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