• Arnaud Bourdin, Gerard Criner, Gilles Devouassoux, Mark Dransfield, Halpin David M G DMG College of Medicine and Health, University of Exeter Medical School, University of Exeter, Exeter, United Kingdom., MeiLan K Han, C Elaine Jones, Ravi Kalhan, Peter Lange, Sally Lettis, David A Lipson, David A Lomas, José M Echave-Sustaeta María-Tomé, Neil Martin, Fernando J Martinez, Holly Quasny, Lynda Sail, Thomas M Siler, Dave Singh, Byron Thomashow, Henrik Watz, Robert Wise, and Nicola A Hanania.
• Department of Pneumology and Addictology, University of Montpellier, CHU Montpellier, Montpellier, France.
• Chronic Obstr Pulm Dis (Miami). 2020 Nov 5.

BackgroundThe IMPACT trial demonstrated lower moderate/severe exacerbation rates with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus FF/VI or UMEC/VI in patients with chronic obstructive pulmonary disease (COPD) and a history of exacerbations. Since IMPACT was a global study, post-hoc analyses were conducted by geographic region to investigate potential differences in overall findings.MethodsIMPACT was a 52-week, randomized, double-blind trial. Patients with symptomatic COPD and ≥1 moderate/severe exacerbation in the prior year were randomized 2:2:1 to once-daily FF/UMEC/VI 100/62.5/25µg, FF/VI 100/25µg, or UMEC/VI 62.5/25µg. Endpoints assessed in the overall, Western Europe (WE) and North America (NA) populations included on-treatment moderate/severe exacerbation (rates and time-to-first), trough forced expiratory volume in 1 second and St George's Respiratory Questionnaire (SGRQ) total score. Safety was assessed.ResultsOverall, 10,355 patients were enrolled, 3164 from WE, 2639 from NA. FF/UMEC/VI significantly reduced on-treatment moderate/severe exacerbation rates versus FF/VI and UMEC/VI in WE (rate ratios 0.82 [95%CI 0.74-0.91], P<.001 and 0.76 [0.67-0.87], P<.001) and NA (0.87 [0.77-0.97], P=.014 and 0.69 [0.60-0.80], P<.001). FF/UMEC/VI reduced time-to-first moderate/severe exacerbation and improved lung function versus FF/VI and UMEC/VI in both regions, and improved SGRQ total score in WE, but not NA. Safety profiles were generally similar between treatment groups/regions; the inhaled corticosteroid class effect of increased pneumonia incidence was seen in NA but not WE.ConclusionConsistent with intent-to-treat results, FF/UMEC/VI reduced moderate/severe exacerbation rate and risk and improved lung function in WE and NA; however, between-regions differences were seen for SGRQ total score and pneumonia incidence.JCOPDF © 2020.

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