17 Sep COPD: Single Inhaler, Fixed-Dose Triple-Combination Therapy Reduced Exacerbations
MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by COPD? How common is severe COPD?
Response: COPD, or chronic obstructive pulmonary disease, is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which can cause obstruction of airflow in the lungs making it hard to breathe. In the United States, COPD is the fourth leading cause of death. Its prevalence in adults 18 years of age and older is 6.5 percent. An estimated 16 million people are currently diagnosed with COPD, and millions more are believed to have it but do not know it.
ETHOS is a randomized, double-blind, multi-center, parallel-group, 52-week trial to assess the efficacy and safety of PT010 in symptomatic patients with moderate to very severe COPD and a history of exacerbation(s) in the previous year. The trial compared two doses given twice daily of PT010 (320/14.4/9.6mcg and 160/14.4/9.6mcg) with glycopyrrolate/formoterol fumarate (14.4/9.6mcg) and PT009 (320/9.6mcg), all using AEROSPHERETM Delivery Technology in a pressurized metered-dose inhaler (pMDI). Outcomes in the ETHOS trial included, as a primary endpoint, the rate of moderate or severe exacerbations.
The Phase III ETHOS trial builds on the Phase III KRONOS data which together show PT010’s ability to reduce exacerbation risk in a broad range of patients with COPD, irrespective of whether they have had an exacerbation in the previous twelve months.
MedicalResearch.com: What is the combination medication PT010? How does it differ from other treatments for COPD?
Response: COPD is a progressive disease, and many patients progress from mono or dual therapy to triple-combination therapy over the course of their disease, based on symptoms, exacerbations risk and other factors. 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). It utilizes AstraZeneca’s AEROSPHERE™ Delivery Technology.
MedicalResearch.com: What are the main findings of this Phase III ETHOS study?
Response: ETHOS trial results showed PT010 dosed at either 320/14.4/9.6mcg or 160/14.4/9.6mcg and administered via a pMDI demonstrated a statistically-significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies glycopyrronium/formoterol fumarate 14.4/9.6mcg, pMDI and PT009 (budesonide/formoterol fumarate 320/9.6mcg, pMDI).
This is the first time the benefit of two doses of an ICS in a fixed-dose closed triple-combination therapy has been established in COPD, which could transform care by allowing physicians to select the optimal dosing option for individual patients.
MedicalResearch.com: What should readers take away from your report?
Response: Exacerbations are devastating events for COPD patients and can lead to a permanent loss of lung function. That is a key reason why closed triple-combination therapies, which can reduce the annual rate of exacerbations versus older dual-combination therapies, are expected to be central to management of COPD. We believe the results are important to further characterize PT010’s strong clinical profile, particularly on exacerbations.
MedicalResearch.com: Is there anything else you would like to add?
Response: We look forward to sharing ETHOS results with health authorities as soon as possible, and we expect triple-combination therapy to be central to management of COPD.
Phase III ETHOS trial for triple-combination therapy PT010 in patients with moderate to very severe chronic obstructive pulmonary disease (COPD)
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Last Updated on September 17, 2019 by Marie Benz MD FAAD