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 o the Western Europe and North America Regions

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

  • Arnaud Bourdin
  • Gerard Criner
  • Gilles Devouassoux
  • Mark Dransfield
  • David M. G. Halpin
  • MeiLan K. Han
  • C. Elaine Jones
  • Ravi Kalhan
  • Sally Lettis
  • David A. Lipson
  • David A. Lomas
  • Jose M. Echave-Sustaeta Maria-Tome
  • Neil Martin
  • Fernando J. Martinez
  • Holly Quasny
  • Lynda Sail
  • Thomas M. Siler
  • Dave Singh
  • Byron Thomashow
  • Henrik Watz
  • Robert Wise
  • Nicola A. Hanania

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 100/62.5/25 mu g, FF/VI 100/25 mu g, or UMEC/VI 62.5/25 mu g. 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

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.

TidsskriftChronic Obstructive Pulmonary Diseases
Udgave nummer1
Sider (fra-til)76-90
Antal sider15
StatusUdgivet - 2021

ID: 258373540