29 Jun COPD: Reduction in Exacerbations and Mortality with Novel Triple Inhaled Therapy
MedicalResearch.com Interview with:
Frank Trudo, MD MBA
Vice President, US Medical Affairs
Respiratory & Immunology
MedicalResearch.com: What is the background for this study?
Response: ETHOS is a randomized, double-blinded, 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. Outcomes in the ETHOS trial included, as a primary endpoint, the rate of moderate or severe exacerbations.
MedicalResearch.com: How does PT010 differ from other treatments for COPD?
- Highly competitive: PT010’s Phase III clinical trial program demonstrates it has a highly competitive clinical profile in decreasing moderate or severe exacerbations. Severe exacerbations were defined as exacerbations leading to hospitalization or death.
- All-cause mortality: In a secondary endpoint, PT010 showed a 46% reduction in the risk of all-cause mortality compared with glycopyrronium/formoterol fumarate. The data from ETHOS show that reducing risk of all-cause mortality is achievable for patients with this progressive disease and could transform treatment goals in COPD.
- Two potential dose options: This is also the first time we have seen the benefit of closed triple-combination therapy at two ICS doses, which could transform care by allowing physicians to select the optimal dosing option for individual patients.
MedicalResearch.com: What are the main findings?
Response: Full results from the positive Phase III ETHOS trial showed that PT010 demonstrated a statistically significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies glycopyrronium/formoterol fumarate and PT009 (budesonide/ formoterol fumarate) in patients with moderate to very severe COPD.
Specifically, PT010 achieved a 24% and 13% reduction in the rate of moderate or severe exacerbations, respectively compared with glycopyrronium/formoterol fumarate and PT009, at the standard dose of budesonide. In a secondary endpoint, PT010 showed a 46% reduction in the risk of all-cause mortality compared with glycopyrronium/formoterol fumarate.
MedicalResearch.com: What should readers take away from your report?
Response: In the US, 366 people die each day from COPD (the fourth leading cause of death in the US) and reducing the risk of exacerbations is a priority in treating COPD. That’s because exacerbations are known to have a negative impact on lung function, quality of life and mortality. In ETHOS, PT010 demonstrated a statistically significant reduction in the rate of moderate to severe exacerbations in patients with moderate to very severe COPD.
Additionally, ETHOS is the first Phase III COPD closed triple-combination therapy trial to include all-cause mortality as a secondary endpoint in the testing hierarchy, with findings showing that that reducing risk of all-cause mortality is achievable for patients with COPD.
We believe the Phase III ETHOS results are important to further characterize PT010’s strong clinical profile, particularly on the reduced rate of exacerbations and risk in all-cause mortality.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Reducing the risk of exacerbations is a priority in treatment of COPD because they are known to have a negative impact on lung function, quality of life and mortality. Research is needed to help identify patients with more mild disease at greatest risk of COPD disease progression.
MedicalResearch.com: Is there anything else you would like to add?
Response: We believe we have one of the most exciting respiratory pipelines in the industry. ETHOS further supports what we believe – that PT010 could be a truly differentiated triple therapy. We are confident in the PT010 file and expect a regulatory decision on market authorization in H2 2020.
Triple Inhaled Therapy at Two Glucocorticoid Doses in Moderate-to-Very-Severe COPD
List of authors.
Klaus F. Rabe, M.D., Ph.D., Fernando J. Martinez, M.D., Gary T. Ferguson, M.D., Chen Wang, M.D., Ph.D., Dave Singh, M.D., Jadwiga A. Wedzicha, M.D., Roopa Trivedi, M.S., Earl St. Rose, M.S., Shaila Ballal, M.S., Julie McLaren, M.D., Patrick Darken, Ph.D., Magnus Aurivillius, M.D., Ph.D., et al., for the ETHOS Investigators*
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