IMPACT (triple therapy vs. umeclidinium/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
34.0% female
66.0% male
N = 6221
6221 patients (2099 female, 4122 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=2070 umeclidinium and vilanterol (umeclidinium 62.5 mcg and vilanterol 25 mcg).
Primary outcome
Incidence of moderate or severe exacerbations
0.91 / y
1.21 / y
1.2/ y
0.9/ y
0.6/ y
0.3/ y
0.0/ y
Fluticasone, umeclidinium, and
vilanterol
Umeclidinium and
vilanterol
Significant
decrease ▼
Significant decrease in the incidence of moderate or severe exacerbations (0.91/ y vs. 1.21/ y; RR 0.75, 95% CI 0.7 to 0.81).
Conclusion
In patients with moderate or severe chronic obstructive lung disease, fluticasone, umeclidinium, and vilanterol were superior to umeclidinium 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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