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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Reduction in Emergency Department (ED) Visits in Patients with Chronic Obstructive Pulmonary Disease (COPD): Analysis of the IMPACT Trial
Session Title
TP40 - TP040 COPD CLINICAL TRIALS AND THERAPIES
Abstract
A2242 - Reduction in Emergency Department (ED) Visits in Patients with Chronic Obstructive Pulmonary Disease (COPD): Analysis of the IMPACT Trial
Author Block: D. W. Mapel1, M. Bogart2, G. J. Criner3, M. T. Dransfield4, N. Gaeckle5, M. Gotfried6, D. M. G. Halpin7, M. K. Han8, R. Jain2, V. Kaul9, M. J. Mammen10, D. Midwinter11, D. Singh12, R. Wise13, D. A. Lipson14; 1University of New Mexico College of Pharmacy, Albuquerque, NM, United States, 2GSK, Research Triangle Park, NC, United States, 3Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States, 4Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, AL, United States, 5Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, University of Minnesota, Minneapolis, MN, United States, 6Pulmonary Associates PA, Phoenix, AZ, United States, 7University of Exeter Medical School, University of Exeter, Exeter, United Kingdom, 8University of Michigan, Pulmonary & Critical Care, Ann Arbor, MI, United States, 9State University of New York Upstate Medical & Crouse Health, Syracuse, NY, United States, 10Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY, United States, 11GSK R&D, GSK House, Brentford, Middlesex, United Kingdom, 12University of Manchester, Manchester University NHS Foundation Trust, Manchester, United Kingdom, 13Johns Hopkins University School of Medicine, Baltimore, MD, United States, 14GSK & Perelman School of Medicine, University of Pennsylvania, Collegeville & Philadelphia, PA, United States.
Rationale: ED visits and hospitalizations associated with COPD place a burden on healthcare systems, and account for most COPD-related healthcare costs in the US. In the IMPACT trial, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) significantly reduced rates of severe exacerbations (resulting in hospitalization or death) versus UMEC/VI in patients with COPD. The rate of ED visits in patients enrolled in IMPACT has not been published; this analysis investigated the annual rate of ED visits by treatment arm for patients with COPD in the IMPACT trial.
Methods: IMPACT was a Phase 3, randomized, double-blind, 52-week trial comparing once-daily FF/UMEC/VI 100/62.5/25µg with FF/VI 100/25µg and UMEC/VI 62.5/25µg. Eligible patients (aged ≥40 years) had symptomatic COPD (COPD Assessment Test score ≥10), a forced expiratory volume in 1 second (FEV1) <50% predicted and ≥1 moderate or severe exacerbation in the prior year, or a FEV1 50-<80% predicted and ≥2 moderate or ≥1 severe exacerbation in the prior year. Unscheduled healthcare resource utilization, including ED visits, was recorded in patients’ electronic case report form. This post hoc analysis quantified annual rates of ED visits for any reason by treatment arm, using a generalized linear model assuming a negative binomial distribution.
Results: The intent-to-treat population comprised 10,355 patients of which data on ED visits were available for 10,351 patients (FF/UMEC/VI, n=4148; FF/VI, n=4134; UMEC/VI, n=2069). Overall, 11.5% (n=477/4148) of patients on FF/UMEC/VI, 10.4% (n=432/4134) on FF/VI, and 12.2% (n=252/2069) on UMEC/VI had 1 ED visit, and 4.4% (n=182/4148), 4.8% (n=199/4134), and 4.2% (n=86/2069), respectively, had ≥2 ED visits. The model estimated annual event rates (95% confidence interval [CI]) were 0.27 (0.24, 0.29), 0.29 (0.26, 0.32), and 0.33 (0.28, 0.37) for FF/UMEC/VI, FF/VI, and UMEC/VI, respectively (Figure). The rate of ED visits for patients on FF/UMEC/VI was significantly lower versus UMEC/VI (18% reduction; rate ratio: 0.82; 95% CI: 0.70, 0.97; p=0.017) but there was no statistically significant difference versus FF/VI (7% reduction; rate ratio: 0.93; 95% CI: 0.81, 1.06; p=0.256).
Conclusions: The rate of ED visits was significantly lower for patients on FF/UMEC/VI compared with UMEC/VI and similar to the FF/VI arm. In addition to the reduction in severe exacerbation rates with FF/UMEC/VI versus UMEC/VI seen in the IMPACT trial, this reduction in ED visits for any reason highlights the benefits of single-inhaler FF/UMEC/VI triple therapy over UMEC/VI dual therapy in patients with symptomatic COPD and a history of exacerbations.
Funding: GSK (CTT116855/NCT02164513).
Author Block: D. W. Mapel1, M. Bogart2, G. J. Criner3, M. T. Dransfield4, N. Gaeckle5, M. Gotfried6, D. M. G. Halpin7, M. K. Han8, R. Jain2, V. Kaul9, M. J. Mammen10, D. Midwinter11, D. Singh12, R. Wise13, D. A. Lipson14; 1University of New Mexico College of Pharmacy, Albuquerque, NM, United States, 2GSK, Research Triangle Park, NC, United States, 3Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States, 4Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, AL, United States, 5Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, University of Minnesota, Minneapolis, MN, United States, 6Pulmonary Associates PA, Phoenix, AZ, United States, 7University of Exeter Medical School, University of Exeter, Exeter, United Kingdom, 8University of Michigan, Pulmonary & Critical Care, Ann Arbor, MI, United States, 9State University of New York Upstate Medical & Crouse Health, Syracuse, NY, United States, 10Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY, United States, 11GSK R&D, GSK House, Brentford, Middlesex, United Kingdom, 12University of Manchester, Manchester University NHS Foundation Trust, Manchester, United Kingdom, 13Johns Hopkins University School of Medicine, Baltimore, MD, United States, 14GSK & Perelman School of Medicine, University of Pennsylvania, Collegeville & Philadelphia, PA, United States.
Rationale: ED visits and hospitalizations associated with COPD place a burden on healthcare systems, and account for most COPD-related healthcare costs in the US. In the IMPACT trial, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) significantly reduced rates of severe exacerbations (resulting in hospitalization or death) versus UMEC/VI in patients with COPD. The rate of ED visits in patients enrolled in IMPACT has not been published; this analysis investigated the annual rate of ED visits by treatment arm for patients with COPD in the IMPACT trial.
Methods: IMPACT was a Phase 3, randomized, double-blind, 52-week trial comparing once-daily FF/UMEC/VI 100/62.5/25µg with FF/VI 100/25µg and UMEC/VI 62.5/25µg. Eligible patients (aged ≥40 years) had symptomatic COPD (COPD Assessment Test score ≥10), a forced expiratory volume in 1 second (FEV1) <50% predicted and ≥1 moderate or severe exacerbation in the prior year, or a FEV1 50-<80% predicted and ≥2 moderate or ≥1 severe exacerbation in the prior year. Unscheduled healthcare resource utilization, including ED visits, was recorded in patients’ electronic case report form. This post hoc analysis quantified annual rates of ED visits for any reason by treatment arm, using a generalized linear model assuming a negative binomial distribution.
Results: The intent-to-treat population comprised 10,355 patients of which data on ED visits were available for 10,351 patients (FF/UMEC/VI, n=4148; FF/VI, n=4134; UMEC/VI, n=2069). Overall, 11.5% (n=477/4148) of patients on FF/UMEC/VI, 10.4% (n=432/4134) on FF/VI, and 12.2% (n=252/2069) on UMEC/VI had 1 ED visit, and 4.4% (n=182/4148), 4.8% (n=199/4134), and 4.2% (n=86/2069), respectively, had ≥2 ED visits. The model estimated annual event rates (95% confidence interval [CI]) were 0.27 (0.24, 0.29), 0.29 (0.26, 0.32), and 0.33 (0.28, 0.37) for FF/UMEC/VI, FF/VI, and UMEC/VI, respectively (Figure). The rate of ED visits for patients on FF/UMEC/VI was significantly lower versus UMEC/VI (18% reduction; rate ratio: 0.82; 95% CI: 0.70, 0.97; p=0.017) but there was no statistically significant difference versus FF/VI (7% reduction; rate ratio: 0.93; 95% CI: 0.81, 1.06; p=0.256).
Conclusions: The rate of ED visits was significantly lower for patients on FF/UMEC/VI compared with UMEC/VI and similar to the FF/VI arm. In addition to the reduction in severe exacerbation rates with FF/UMEC/VI versus UMEC/VI seen in the IMPACT trial, this reduction in ED visits for any reason highlights the benefits of single-inhaler FF/UMEC/VI triple therapy over UMEC/VI dual therapy in patients with symptomatic COPD and a history of exacerbations.
Funding: GSK (CTT116855/NCT02164513).
