22 Aug Triple-Drug Inhaler vs Dual Therapy for COPD
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 was 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. A subset of patients participated in the 4-hour pulmonary function test (PFT) sub-study, with the following primary endpoints: change from baseline in morning pre-dose trough FEV1 at Week 24 at (both doses of budesonide/glycopyrrolate/formoterol fumarate MDI versus glycopyrrolate/formoterol fumarate MDI), and FEV1 area under the curve from 0-4 hours at Week 24 (both doses of budesonide/glycopyrrolate/formoterol fumarate MDI vs budesonide/formoterol fumarate MDI).
MedicalResearch.com: What are the main findings?
Response: The pulmonary function test modified intent-to-treat population included a total of 3088 patients (mean age 64.4 years; 52.8% male; mean post-albuterol FEV1 % predicted 42.8). The results showed that both budesonide/glycopyrrolate/formoterol fumarate MDI 320/18/9.6µg and budesonide/glycopyrrolate/formoterol fumarate MDI 160/18/9.6µg significantly improved trough FEV1 versus glycopyrrolate/formoterol fumarate MDI and FEV1 AUC0-4 versus budesonide/formoterol fumarate MDI at Week 24. The lung function benefits with both doses of budesonide/glycopyrrolate/formoterol fumarate MDI were maintained after 52 weeks of treatment.
MedicalResearch.com: What should readers take away from your report?
Response: There are approximately 15.7 million people identified as having COPD in the US and an estimated millions more who remain undiagnosed. Reducing the risk of exacerbations should be a priority in treatment of COPD because they are known to have a negative impact on lung function, quality of life and mortality.
In this sub-study, both BGF MDI 320/18/9.6µg and BGF MDI 160/18/9.6µg significantly improved trough FEV1 versus GFF MDI and FEV1 AUC0-4 versus BFF MDI at Week 24. The lung function benefits with both doses of BGF MDI were maintained after 52 weeks of treatment.
The Phase III ETHOS results further support what we believe – that BREZTRI AEROSPHERE could be a truly differentiated triple therapy.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Today, most patients diagnosed with COPD are on an inhaled therapy, but for patients who develop further exacerbations on ICS/LABA therapy, escalating to triple therapy by adding a LAMA should be considered. There is potential for a more proactive treatment approach in COPD, where clinicians aim to reduce the risk of exacerbations and hospitalizations, with triple-combination therapy playing a central role in treating moderate to very severe COPD.
MedicalResearch.com: Is there anything else you would like to add?
Response: AstraZeneca’s BREZTRI AEROSPHERETM (budesonide/glycopyrrolate/formoterol fumarate) was recently approved in the US for the maintenance treatment of patients with COPD.
ATS 2020 abstract:
Improvements in Lung Function with Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Versus Dual Therapies in Patients with COPD: A Sub-study of the ETHOS Trial
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Last Updated on August 22, 2020 by Marie Benz MD FAAD