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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Safety and Efficacy of Budesonide-Glycopyrrolate-Formoterol Fumarate for COPD in Black or African-American Patients: A Post-Hoc Subgroup Analysis of the ETHOS Study
Session Title
TP1 - TP001 MECHANISTIC AND TRANSLATIONAL STUDIES IN COPD
Abstract
A1244 - Safety and Efficacy of Budesonide-Glycopyrrolate-Formoterol Fumarate for COPD in Black or African-American Patients: A Post-Hoc Subgroup Analysis of the ETHOS Study
Author Block: M. K. Han1, M. Jenkins2, D. Carstens3, M. Patel2, N. Feigler3; 1University of Michigan School of Medicine, Ann Arbor, MI, United States, 2AstraZeneca, Cambridge, United Kingdom, 3AstraZeneca, Wilmington, DE, United States.
Rationale: The budesonide-glycopyrrolate-formoterol fumarate metered dose inhaler (BGF MDI) is a triple fixed-dose combination for chronic obstructive pulmonary disease (COPD). The phase 3, randomized, double-blind, parallel group ETHOS study (NCT02465567) demonstrated that BGF MDI resulted in significantly lower rates of moderate or severe exacerbations versus dual therapies. This post-hoc analysis evaluated the efficacy and safety of BGF MDI in the Black or African-American subgroup of the global ETHOS study population to assess consistency with the total study population. Methods: Eligible participants (40 to 80 years of age with symptomatic COPD with ≥1 exacerbation in the prior year) were randomly assigned 1:1:1:1 to receive BGF MDI containing 320µg or 160µg budesonide, glycopyrrolate-formoterol fumarate (GFF) MDI, or budesonide-formoterol fumarate (BFF) MDI over 52 weeks. The annual rate of moderate or severe COPD exacerbations (primary endpoint), the annual rate of severe exacerbations, and adverse events were evaluated in this post-hoc analysis of the subgroup of Black or African-American participants. Results: The Black or African-American subgroup included 305 participants (320µg BGF MDI, n=78; 160µg BGF MDI, n=88; GFF MDI, n=75; BFF MDI, n=64), comprising 3.6% of the overall study population. Of note, from the 3013 participants in the US population studied in ETHOS, Black or African American participants comprised 9.5% of the population (n=287). Baseline demographics were similar across treatment groups and consistent with the overall study population. The adjusted annual rates of moderate or severe exacerbations for Black or African-American participants were: 320µg BGF MDI, 0.95; 160µg BGF MDI, 1.21; GFF MDI, 1.72; BFF MDI, 1.11. The annual rate of moderate or severe exacerbations was lower for those receiving 320µg BGF MDI versus those receiving GFF MDI or BFF MDI (rate ratios 0.55 and 0.85, Table). Estimated benefits were as large as those observed in the overall population (rate ratios 0.76 vs GFF MDI and 0.87 vs BFF MDI). Those treated with 320µg BGF MDI also had a lower rate of severe exacerbations versus the other treatment groups (Table). All treatments were well-tolerated in the Black or African-American subgroup, similar to the overall population. Conclusions: In the subgroup of Black or African-American participants, the rates of moderate or severe exacerbations, as well as severe exacerbations, were lower with BGF MDI versus both dual therapies. These results were consistent with the overall population, and suggest that BGF MDI will be an important treatment option for Black or African-American individuals with moderate-to-very-severe COPD. Funding: AstraZeneca
Author Block: M. K. Han1, M. Jenkins2, D. Carstens3, M. Patel2, N. Feigler3; 1University of Michigan School of Medicine, Ann Arbor, MI, United States, 2AstraZeneca, Cambridge, United Kingdom, 3AstraZeneca, Wilmington, DE, United States.
Rationale: The budesonide-glycopyrrolate-formoterol fumarate metered dose inhaler (BGF MDI) is a triple fixed-dose combination for chronic obstructive pulmonary disease (COPD). The phase 3, randomized, double-blind, parallel group ETHOS study (NCT02465567) demonstrated that BGF MDI resulted in significantly lower rates of moderate or severe exacerbations versus dual therapies. This post-hoc analysis evaluated the efficacy and safety of BGF MDI in the Black or African-American subgroup of the global ETHOS study population to assess consistency with the total study population. Methods: Eligible participants (40 to 80 years of age with symptomatic COPD with ≥1 exacerbation in the prior year) were randomly assigned 1:1:1:1 to receive BGF MDI containing 320µg or 160µg budesonide, glycopyrrolate-formoterol fumarate (GFF) MDI, or budesonide-formoterol fumarate (BFF) MDI over 52 weeks. The annual rate of moderate or severe COPD exacerbations (primary endpoint), the annual rate of severe exacerbations, and adverse events were evaluated in this post-hoc analysis of the subgroup of Black or African-American participants. Results: The Black or African-American subgroup included 305 participants (320µg BGF MDI, n=78; 160µg BGF MDI, n=88; GFF MDI, n=75; BFF MDI, n=64), comprising 3.6% of the overall study population. Of note, from the 3013 participants in the US population studied in ETHOS, Black or African American participants comprised 9.5% of the population (n=287). Baseline demographics were similar across treatment groups and consistent with the overall study population. The adjusted annual rates of moderate or severe exacerbations for Black or African-American participants were: 320µg BGF MDI, 0.95; 160µg BGF MDI, 1.21; GFF MDI, 1.72; BFF MDI, 1.11. The annual rate of moderate or severe exacerbations was lower for those receiving 320µg BGF MDI versus those receiving GFF MDI or BFF MDI (rate ratios 0.55 and 0.85, Table). Estimated benefits were as large as those observed in the overall population (rate ratios 0.76 vs GFF MDI and 0.87 vs BFF MDI). Those treated with 320µg BGF MDI also had a lower rate of severe exacerbations versus the other treatment groups (Table). All treatments were well-tolerated in the Black or African-American subgroup, similar to the overall population. Conclusions: In the subgroup of Black or African-American participants, the rates of moderate or severe exacerbations, as well as severe exacerbations, were lower with BGF MDI versus both dual therapies. These results were consistent with the overall population, and suggest that BGF MDI will be an important treatment option for Black or African-American individuals with moderate-to-very-severe COPD. Funding: AstraZeneca
