IMPACT (triple therapy vs. fluticasone/vilanterol)
Trial question
What is the effect of triple therapy with fluticasone furoate, umeclidinium, and vilanterol in patients with moderate or severe COPD?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
33.0% female
67.0% male
N = 8285
8285 patients (2771 female, 5514 male).
Inclusion criteria: patients with moderate or severe chronic obstructive lung disease.
Interventions
N=4151 fluticasone, umeclidinium, and vilanterol (fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg).
N=4134 fluticasone and vilanterol (fluticasone 100 mcg and vilanterol 25 mcg).
Primary outcome
Incidence of moderate or severe exacerbations
0.91 / y
1.07 / y
1.1/ y
0.8/ y
0.5/ y
0.3/ y
0.0/ y
Fluticasone, umeclidinium, and
vilanterol
Fluticasone and
vilanterol
Significant
decrease ▼
Significant decrease in the incidence of moderate or severe exacerbations (0.91/ y vs. 1.07/ y; RR 0.85, 95% CI 0.8 to 0.9).
Conclusion
In patients with moderate or severe chronic obstructive lung disease, fluticasone, umeclidinium, and vilanterol were superior to fluticasone and vilanterol with respect to the incidence of moderate or severe exacerbations.
Reference
Lipson DA, Barnhart F, Brealey N et al. Once-Daily Single-Inhaler Triple versus Dual Therapy in Patients with COPD. N Engl J Med. 2018 May 3;378(18):1671-1680.
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