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.
Search Tips:
- Use the keyword search to search by keyword or author's name.
- Filter your search results by selecting the checkboxes that apply.
- Click on "Clear" to clear the form and start a new search. .
Search results will display below the form.
Benefits of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler in Patients with Chronic Obstructive Pulmonary Disease by Baseline CAT Score: Post-Hoc Analysis of the ETHOS Study
Session Title
TP40 - TP040 COPD CLINICAL TRIALS AND THERAPIES
Abstract
A2246 - Benefits of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler in Patients with Chronic Obstructive Pulmonary Disease by Baseline CAT Score: Post-Hoc Analysis of the ETHOS Study
Author Block: J. Hurst1, F. J. Martinez2, D. Singh3, P. Darken4, M. Patel5, P. Dorinsky6; 1UCL Respiratory, University College London, London, United Kingdom, 2Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York, NY, United States, 3Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester, United Kingdom, 4AstraZeneca, Wilmington, DE, United States, 5AstraZeneca, Cambridge, United Kingdom, 6AstraZeneca, Durham, NC, United States.
Rationale: Budesonide/glycopyrrolate/formoterol fumarate (BGF) is a triple fixed-dose combination (inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β2-agonist) for the treatment of chronic obstructive pulmonary disease (COPD). Since symptoms primarily drive patient/physician interactions and decision-making in COPD, we assessed the efficacy and safety of BGF versus dual therapies in subgroups defined by baseline COPD Assessment Test (CAT) scores in this post-hoc analysis of the ETHOS study. Methods: The randomized, double-blind, 52-week, phase III, ETHOS (NCT02465567) study evaluated BGF (320/18/9.6 µg and 160/18/9.6 µg) versus glycopyrrolate/formoterol fumarate (GFF) 18/9.6 µg and budesonide/formoterol fumarate (BFF) 320/9.6 µg, all delivered via a single metered dose Aerosphere inhaler. Patients with moderate-to-very severe COPD, CAT score ≥10, and ≥1 moderate/severe exacerbation in the previous year (forced expiratory volume in 1 second [FEV1] <50% predicted) or ≥2 moderate/≥1 severe (FEV1 ≥50% predicted) were included. This post-hoc analysis evaluated exacerbation rates, health-related quality of life (St George’s Respiratory Questionnaire [SGRQ] total score) and lung function (trough FEV1 and FEV1 area under the concentration-time curve from 0 to 4 hours [AUC0-4]) in subgroups defined by a baseline CAT score of ≥10-<20 (hereafter referred to as <20) and ≥20. Results: Overall, 8509 patients were included in the modified intent-to-treat population. Baseline demographics were generally similar between subgroups defined by baseline CAT score <20 (N=4338) or ≥20 (N=4149). Outcomes by baseline CAT group are presented in the Table. Both doses of BGF reduced moderate/severe exacerbation rates versus dual therapies; benefits with BGF 320/18/9.6 µg were numerically larger in the CAT ≥20 subgroup while those for BGF 160/18/9.6 µg were numerically larger in the CAT <20 subgroup. For SGRQ score, improvements were observed with both BGF doses versus dual therapies for both CAT subgroups. Increases were observed in trough FEV1 and FEV1 AUC0-4 with both BGF doses compared with dual therapies, with similar findings across CAT subgroups. The overall incidence of treatment-emergent adverse events was similar for CAT <20 and ≥20 subgroups (62.3% vs 64.7% of patients, respectively). Conclusion: Symptoms are a key driver of treatment decision-making in COPD. The current analysis indicates that BGF triple therapy reduced exacerbations and improved quality of life and lung function versus dual therapies in both CAT subgroups. These findings indicate that the benefits of BGF triple versus dual therapies were evident across a spectrum of symptom severities and were not driven by those with the greatest symptom burden at baseline.
Author Block: J. Hurst1, F. J. Martinez2, D. Singh3, P. Darken4, M. Patel5, P. Dorinsky6; 1UCL Respiratory, University College London, London, United Kingdom, 2Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York, NY, United States, 3Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester, United Kingdom, 4AstraZeneca, Wilmington, DE, United States, 5AstraZeneca, Cambridge, United Kingdom, 6AstraZeneca, Durham, NC, United States.
Rationale: Budesonide/glycopyrrolate/formoterol fumarate (BGF) is a triple fixed-dose combination (inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β2-agonist) for the treatment of chronic obstructive pulmonary disease (COPD). Since symptoms primarily drive patient/physician interactions and decision-making in COPD, we assessed the efficacy and safety of BGF versus dual therapies in subgroups defined by baseline COPD Assessment Test (CAT) scores in this post-hoc analysis of the ETHOS study. Methods: The randomized, double-blind, 52-week, phase III, ETHOS (NCT02465567) study evaluated BGF (320/18/9.6 µg and 160/18/9.6 µg) versus glycopyrrolate/formoterol fumarate (GFF) 18/9.6 µg and budesonide/formoterol fumarate (BFF) 320/9.6 µg, all delivered via a single metered dose Aerosphere inhaler. Patients with moderate-to-very severe COPD, CAT score ≥10, and ≥1 moderate/severe exacerbation in the previous year (forced expiratory volume in 1 second [FEV1] <50% predicted) or ≥2 moderate/≥1 severe (FEV1 ≥50% predicted) were included. This post-hoc analysis evaluated exacerbation rates, health-related quality of life (St George’s Respiratory Questionnaire [SGRQ] total score) and lung function (trough FEV1 and FEV1 area under the concentration-time curve from 0 to 4 hours [AUC0-4]) in subgroups defined by a baseline CAT score of ≥10-<20 (hereafter referred to as <20) and ≥20. Results: Overall, 8509 patients were included in the modified intent-to-treat population. Baseline demographics were generally similar between subgroups defined by baseline CAT score <20 (N=4338) or ≥20 (N=4149). Outcomes by baseline CAT group are presented in the Table. Both doses of BGF reduced moderate/severe exacerbation rates versus dual therapies; benefits with BGF 320/18/9.6 µg were numerically larger in the CAT ≥20 subgroup while those for BGF 160/18/9.6 µg were numerically larger in the CAT <20 subgroup. For SGRQ score, improvements were observed with both BGF doses versus dual therapies for both CAT subgroups. Increases were observed in trough FEV1 and FEV1 AUC0-4 with both BGF doses compared with dual therapies, with similar findings across CAT subgroups. The overall incidence of treatment-emergent adverse events was similar for CAT <20 and ≥20 subgroups (62.3% vs 64.7% of patients, respectively). Conclusion: Symptoms are a key driver of treatment decision-making in COPD. The current analysis indicates that BGF triple therapy reduced exacerbations and improved quality of life and lung function versus dual therapies in both CAT subgroups. These findings indicate that the benefits of BGF triple versus dual therapies were evident across a spectrum of symptom severities and were not driven by those with the greatest symptom burden at baseline.
