InforMing the PAthway of COPD Treatment (IMPACT Trial) Single-Inhaler Triple Therapy (Fluticasone Furoate/Umeclidinium/ Vilanterol) Versus Fluticasone Furoate/Vilanterol and Umeclidinium/Vilanterol in Patients with COPD: Analysis of the Western Europe and North America Regions

Arnaud Bourdin, Gerard Criner, Gilles Devouassoux, Mark Dransfield, David M.G. Halpin, Mei Lan 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 ThomashowHenrik Watz, Robert Wise, Nicola A. Hanania*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Background: The InforMing the Pathway of COPD Treatment (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. Methods: IMPACT 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 and North America 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. Results: Overall, 10,355 patients were enrolled, 3164 from Western Europe, 2639 from North America. FF/ UMEC/VI significantly reduced on-treatment moderate/severe exacerbation rates versus FF/VI and UMEC/ VI in Western Europe (rate ratios 0.82 [95% CI 0.74-0.91], P<.001 and 0.76 [0.67-0.87], P<.001) and in North America (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 Western Europe, but not North America. Safety profiles were generally similar between treatment groups/regions; the inhaled corticosteroid class effect of increased pneumonia incidence was seen in North America but not Western Europe. Conclusions: Consistent with intent-to-treat results, FF/UMEC/VI reduced moderate/severe exacerbation rate and risk and improved lung function in Western Europe and North America; however, between-regions differences were seen for SGRQ total score and pneumonia incidence.

Original languageEnglish (US)
Pages (from-to)76-90
Number of pages15
JournalChronic Obstructive Pulmonary Diseases
Volume8
Issue number1
DOIs
StatePublished - 2021

Keywords

  • COPD
  • Exacerbations
  • North America
  • Single-inhaler triple therapy
  • Western Europe

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

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