Browse ATS 2021 Abstracts

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ATS 2021 will feature presentations of original research from accepted abstracts. Mini Symposia and Thematic Poster Sessions are abstract based sessions.

Please use the form below to browse scientific abstracts and case reports accepted for ATS 2021. Abstracts presented at the ATS 2021 will be published in the Online Abstract Issue of the American Journal of Respiratory and Critical Care Medicine, Volume 203, May 3, 2021.

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Benefits of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler in Patients with Moderate Chronic Obstructive Pulmonary Disease in the ETHOS Study

Session Title
TP40 - TP040 COPD CLINICAL TRIALS AND THERAPIES
Abstract
A2244 - Benefits of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler in Patients with Moderate Chronic Obstructive Pulmonary Disease in the ETHOS Study
Author Block: G. T. Ferguson1, K. F. Rabe2, D. Singh3, M. Jenkins4, M. Patel4, M. Aurivillius5; 1Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, United States, 2LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany, 3Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester, United Kingdom, 4AstraZeneca, Cambridge, United Kingdom, 5AstraZeneca, Gothenburg, Sweden.
Rationale: Triple therapy reduces exacerbations and improves symptoms and lung function in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD) who continue to have symptoms or exacerbations despite dual therapy. To demonstrate that benefits were not driven only by patients with severe or very severe COPD, we report outcomes in the subset of patients from the ETHOS study with moderate COPD based on post-bronchodilator lung function assessed during screening. Methods: ETHOS (NCT02465567) was a phase III, randomized, double-blind, 52-week study that evaluated the efficacy and safety of budesonide/glycopyrrolate/formoterol fumarate (BGF) 320/18/9.6µg and 160/18/9.6µg versus glycopyrrolate/formoterol fumarate (GFF) 18/9.6µg and budesonide/formoterol fumarate (BFF) 320/9.6µg in patients with moderate-to-very severe COPD, post-bronchodilator forced expiratory volume in 1 second (FEV1) 25-65% of predicted, and ≥1 moderate/severe exacerbation in the previous year. All treatments were administered via a metered dose Aerosphere inhaler. Here, we report results for the subgroup of patients with moderate COPD (FEV1 ≥50%) for the following endpoints: rate of moderate or severe exacerbations, lung function, St George’s Respiratory Questionnaire (SGRQ) scores, rescue medication use, and time to clinically important deterioration (CID). Results: The modified intent-to-treat population included 8509 patients, of whom 2427 had moderate COPD at baseline. For efficacy outcomes see Table. BGF 320/18/9.6µg and 160/18/9.6µg reduced the rate of moderate/severe exacerbations versus GFF (rate ratios of 0.79 and 0.70, respectively; unadjusted p=0.0123 and p=0.0002), with numerical improvements seen for both doses of BGF versus BFF. Improvements in lung function outcomes (trough FEV1 and FEV1 AUC0-4) were observed for both BGF doses versus dual therapies, with larger benefits versus BFF than versus GFF. A higher proportion of patients receiving BGF 320/18/9.6µg achieved the minimum clinically important difference in SGRQ total score (decrease of ≥4 units; 53.7%) versus GFF (46.9%); proportions were also numerically higher for BGF 320/18/9.6µg vs BFF (50.6%) and for BGF 160/18/9.6µg versus both dual therapies. Reductions in rescue medication use and an increased time to clinically important deterioration were also observed for both doses of BGF versus GFF, with numerical improvements for BGF versus BFF. Conclusion: Consistent with the overall ETHOS population, BGF showed benefits versus dual therapies on exacerbations, CID, symptoms and quality of life among patients with moderate COPD, with larger effects versus GFF on exacerbations and symptoms and larger effects versus BFF on lung function. Taken together, these findings demonstrate that triple therapy provides benefits for a wide spectrum of patients with COPD.