Triple inhaled therapy of formoterol/glycopyrrolate/budesonide reduces the use of oral corticosteroids and antibiotics during COPD exacerbations in real-world conditions.

Introduction: Triple inhaled therapy (TT) in one device has been shown in clinical trials to reduce exacerbations and in some cases mortality compared to dual inhaled therapy (DT) in one device in the population of moderate to very severe COPD patients and previous exacerbations. This evidence must be contrasted in real-world conditions.

Patients and methods: Non-intervention retrospective cohort study comparing the incidence of moderate and severe exacerbations in COPD patients treated with TT (formoterol, glycopyrrolate and budesonide, 5mcg/72mcg/320mcg, n=112) and DT (LAMA/LABA/ or LABA/inhaled glucocorticoid, n=107) for 26 weeks under clinical practice conditions. Moderate exacerbations were evaluated by the use of oral corticosteroids and/or courses of oral antibiotics and/or attendance at the emergency room (<24h) without hospitalization. Severe exacerbations were analyzed for hospitalizations for all causes, respiratory causes, cardiovascular causes, and pneumonia. Descriptive statistics for qualitative and quantitative variables, Chi square, Student's t-test and multivariate analysis were performed.

Results: Both cohorts were homogeneous except for age (71.46 vs 66.65 TT vs DT, p<0.01). TT reduced the use of oral corticosteroids by 42% (HR 0.58; 95%CI 0.41-0.82, p<0.01) and the use of antibiotics by 25% (HR 0.75; 95%CI 0.60-0.94, p<0.01). Hospitalizations due to respiratory causes were 11% lower in the TT cohort (HR 0.89; 95%CI 0.79-0.99, p=0.044) with no difference in the incidence of pneumonia.

Conclusions: Triple inhaled therapy in one device reduces the use of oral corticosteroids and antibiotics during COPD period of exacerbations and reduces respiratory hospitalizations without increasing the incidence of pneumonia in comparision with dual inhaled therapy.