The effect of exacerbation history on outcomes in the IMPACT trial

David M G Halpin, Mark T Dransfield, MeiLan K Han, C Elaine Jones, Sally Kilbride, Peter Lange, David A Lipson, David A Lomas, Fernando J Martinez, Steve Pascoe, Dave Singh, Robert Wise, Gerard J Criner

Abstract

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.

Original languageEnglish
JournalThe European respiratory journal
Volume55
Issue number5
ISSN0903-1936
DOIs
Publication statusPublished - May 2020

Keywords

  • Administration, Inhalation
  • Adrenergic beta-2 Receptor Agonists/administration & dosage
  • Aged
  • Androstadienes/administration & dosage
  • Benzyl Alcohols/administration & dosage
  • Bronchodilator Agents/administration & dosage
  • Chlorobenzenes/administration & dosage
  • Disease Progression
  • Double-Blind Method
  • Drug Combinations
  • Female
  • Health Status
  • Humans
  • Lung/drug effects
  • Male
  • Middle Aged
  • Muscarinic Antagonists/administration & dosage
  • Nebulizers and Vaporizers
  • Pulmonary Disease, Chronic Obstructive/diagnosis
  • Quinuclidines/administration & dosage
  • Recovery of Function
  • Time Factors
  • Treatment Outcome

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