This article is part of Pulmonology Advisor’s coverage of the CHEST Virtual 2020 meeting.
In patients with moderate to very severe chronic obstructive pulmonary disease (COPD), the use of an inhaled corticosteroid (ICS) in dual and triple therapy doses may reduce the yearly decline in lung function as opposed to treatment with a long-acting muscarinic antagonist/long-acting beta-agonist (LAMA/LABA), according to research presented at the 2020 CHEST Annual Meeting, held virtually October 18 to 21.
The phase 3 ETHOS study (ClinicalTrials.gov Identifier: NCT02465567) was conducted to assess the efficacy and safety of the ICS/LAMA/LABA budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BFG MDI) at 2 different budesonide dose levels in patients with chronic COPD. In the current study, researchers evaluated the ETHOS 52-week pulmonary function test (PFT) substudy in which lung function decline with ICS-containing therapies was evaluated against a non-ICS-containing therapy glycopyrrolate/formoterol fumarate (GFF) MDI.
Patients who had experienced 1 or more moderate/severe exacerbations in the previous year were included in the study; patients received BGF MDI 320/18/9.6
µg, BGF MDI 160/18/9.6 µg, GFF MDI 18/9.6 µg, or BFF MDI 320/9.6 µg twice daily, each administered via a single inhaler, for 52 weeks. The rates of decline in predose trough forced expiratory volume in 1 second (FEV1) and FEV1 AUC0-4 during the 52 weeks were assessed in the pooled ICS-containing treatment arms vs non-ICS-containing treatment arms.
The substudy included 3088 patients (pooled ICS group, n=2309; GFF MDI 18/9.6 µg, n=779) with an average age of 64.4 years and the majority being men (52.8%). The adjusted rate of decline in predose trough FEV1 during the 52 weeks in the pooled ICS-containing treatment group was 37.7 mL per year vs 54.0 mL per year in GFF MDI 18/9.6 µg group (treatment difference, -16.4 mL/y, 95% CI, -36.4 to 3.6).
For FEV1 AUC0-4, the adjusted rate of decline over 52 weeks was 56.1 mL per year in the pooled ICS-containing treatment group and 63.6 mL per year in the GFF MDI 18/9.6 µg group, representing a treatment difference of -7.5 mL per year (95% CI, -26.5 to 11.6).
“Despite the severity of disease in this population, this analysis identified a trend for lower rates of lung function decline in patients receiving an ICS-containing treatment relative to the treatment that did not contain an ICS, GFF MDI 18/9.6 µg, in patients with [moderate to very] severe COPD,” concluded the study authors.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Ferguson G, Martinez F, Rabe K, et al. Benefits of budesonide-containing therapies on reducing lung function decline in patients with COPD in the ETHOS study. Presented at: the CHEST Virtual Annual Meeting; October 18-21, 2020. Abstract 1656.
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