TY - JOUR
T1 - The effect of exacerbation history on outcomes in the impact trial
AU - Halpin, David M.G.
AU - Dransfield, Mark T.
AU - Han, Mei Lan K.
AU - Elaine Jones, C.
AU - Kilbride, Sally
AU - Lange, Peter
AU - Lipson, David A.
AU - Lomas, David A.
AU - Martinez, Fernando J.
AU - Pascoe, Steve
AU - Singh, Dave
AU - Wise, Robert
AU - Criner, Gerard J.
N1 - Funding Information:
Editorial support (in the form of writing assistance, assembling figures, collating author comments, grammatical editing and referencing) was provided by Chrystelle Rasamison and Rachel Edwards (Fishawack Indicia Ltd, UK), and was funded by GSK. This study was funded by GSK (study number CTT116855). The funders of the study had a role in the study design, data analysis, data interpretation and writing of the report.
Funding Information:
Acknowledgements: Editorial support (in the form of writing assistance, assembling figures, collating author comments, grammatical editing and referencing) was provided by Chrystelle Rasamison and Rachel Edwards (Fishawack Indicia Ltd, UK), and was funded by GSK. This study was funded by GSK (study number CTT116855). The funders of the study had a role in the study design, data analysis, data interpretation and writing of the report.
Funding Information:
Support statement: This study was funded by GSK (grant: CTT116855, NCT02164513). Funding information for this article has been deposited with the Crossref Funder Registry.
Publisher Copyright:
Copyright © ERS 2020.
PY - 2020/6
Y1 - 2020/6
N2 - IMPACT, a 52-week, randomised, double-blind trial, assessed the efficacy and safety of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus FF/VI or UMEC/VI in patients with symptomatic COPD and a history of exacerbations. Subgroup analyses assessed whether the efficacy of FF/UMEC/VI versus FF/VI or UMEC/VI and UMEC/VI versus FF/VI varies according to prior exacerbation history, and the combined effects of exacerbation history and blood eosinophil counts. Three subgroups were defined: single moderate (1 moderate/no severe; n=3056 (30%)), frequent moderate (≧2 moderate/no severe; n=4628 (45%)) and severe (≧1 severe/any moderate; n=2671 (26%)). End-points included annual on-treatment moderate/severe exacerbation rate (pre-specified), lung function and health status (both post-hoc). Moderate/severe exacerbation rates (reduction % (95% CI)) were reduced in the FF/UMEC/VI group versus FF/VI (single moderate 20% (10–29), frequent moderate 11% (2–19), severe 17% (7–26)) and versus UMEC/VI (single moderate 18% (5–29), frequent moderate 29% (21–37), severe 26% (14–35)). Moderate/severe exacerbation rates were reduced in the FF/VI group versus UMEC/VI in the frequent moderate subgroup; a numerical reduction was observed in the severe subgroup (single moderate 2% (-12–18), frequent moderate 21% (11–29), severe 11% (-3–22)). Moderate/severe exacerbation rates were lower in the FF/VI group compared with UMEC/VI in patients with higher eosinophil counts. FF/UMEC/VI improved lung function and health status versus both dual therapies irrespective of exacerbation subgroup. UMEC/VI improved lung function versus FF/VI in all subgroups. Triple therapy was more effective than dual regardless of exacerbation history, consistent with results in the intent-to-treat population. Comparisons between dual therapies were influenced by prior exacerbation history and eosinophil counts.
AB - IMPACT, a 52-week, randomised, double-blind trial, assessed the efficacy and safety of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy versus FF/VI or UMEC/VI in patients with symptomatic COPD and a history of exacerbations. Subgroup analyses assessed whether the efficacy of FF/UMEC/VI versus FF/VI or UMEC/VI and UMEC/VI versus FF/VI varies according to prior exacerbation history, and the combined effects of exacerbation history and blood eosinophil counts. Three subgroups were defined: single moderate (1 moderate/no severe; n=3056 (30%)), frequent moderate (≧2 moderate/no severe; n=4628 (45%)) and severe (≧1 severe/any moderate; n=2671 (26%)). End-points included annual on-treatment moderate/severe exacerbation rate (pre-specified), lung function and health status (both post-hoc). Moderate/severe exacerbation rates (reduction % (95% CI)) were reduced in the FF/UMEC/VI group versus FF/VI (single moderate 20% (10–29), frequent moderate 11% (2–19), severe 17% (7–26)) and versus UMEC/VI (single moderate 18% (5–29), frequent moderate 29% (21–37), severe 26% (14–35)). Moderate/severe exacerbation rates were reduced in the FF/VI group versus UMEC/VI in the frequent moderate subgroup; a numerical reduction was observed in the severe subgroup (single moderate 2% (-12–18), frequent moderate 21% (11–29), severe 11% (-3–22)). Moderate/severe exacerbation rates were lower in the FF/VI group compared with UMEC/VI in patients with higher eosinophil counts. FF/UMEC/VI improved lung function and health status versus both dual therapies irrespective of exacerbation subgroup. UMEC/VI improved lung function versus FF/VI in all subgroups. Triple therapy was more effective than dual regardless of exacerbation history, consistent with results in the intent-to-treat population. Comparisons between dual therapies were influenced by prior exacerbation history and eosinophil counts.
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U2 - 10.1183/13993003.51921-2019
DO - 10.1183/13993003.51921-2019
M3 - Article
C2 - 32299860
AN - SCOPUS:85089976858
VL - 55
JO - European Respiratory Journal, Supplement
JF - European Respiratory Journal, Supplement
SN - 0903-1936
IS - 6
M1 - 1901921
ER -