Indacaterol 85 microg / glycopyrronium 43 microg once daily
Population
1532 patients with symptomatic COPD, severe or very severe airflow limitation, and an exacerbation in the previous year
Follow-up
52 weeks
Primary endpoint
Rate of moderate-to-severe COPD exacerbations
Result
0.50 per patient-year (95% CI 0.45 to 0.57) with triple therapy versus 0.59 (0.53 to 0.67) with indacaterol/glycopyrronium — rate ratio 0.848 (0.723 to 0.995, p=0.043). Pneumonia occurred in 28 of 764 (4%) versus 27 of 768 (4%).
Secondary endpoints
Lung function, symptoms, adverse events including pneumonia
In patients with symptomatic COPD, severe or very severe airflow limitation, and an exacerbation history despite maintenance therapy, extrafine BDP/FF/G significantly reduced the rate of moderate-to-severe exacerbations compared with IND/GLY, without increasing the risk of pneumonia.
The trial authors, in the published abstract
How it has aged
A smaller and more marginal result than IMPACT or ETHOS — the confidence interval very nearly crosses one. Its distinctive finding is the absence of a pneumonia signal, which has been attributed to the extrafine formulation and the lower steroid dose, though the trial was not powered to settle that.
Publications
Extrafine inhaled triple therapy versus dual bronchodilator therapy in chronic obstructive pulmonary disease (TRIBUTE): a double-blind, parallel group, randomised controlled trial
Papi A, Vestbo J, Fabbri L, et al. Extrafine inhaled triple therapy versus dual bronchodilator therapy in chronic obstructive pulmonary disease (TRIBUTE): a double-blind, parallel group, randomised controlled trial. Lancet 2018 Mar 17;391(10125):1076-1084.
15% lower moderate-to-severe exacerbation rate than indacaterol/glycopyrronium
No increase in pneumonia with the inhaled steroid-containing arm