Late Breaking Abstract - Reduction of COPD exacerbations with extrafine single inhaler triple therapy: post-hoc analysis by exacerbation treatment of the TRIBUTE study

Rationale and objective: Treatment of COPD exacerbations with antibiotics and/or systemic corticosteroids maybe related to a different degree of event severity. TRIBUTE was a 52-week randomised controlled study showing a superior clinical effect with extrafine beclometasone dipropionate/formoterol fumarate/glycopyrronium (BDP/FF/G 87/5/9 µg) compared to (IND/GLY 85/43 µg) in reducing moderate/severe exacerbations in 1532 symptomatic COPD patients with a history of exacerbation. We investigated whether this effect was confirmed regardless of the type of event treatment. Methods: Information on exacerbation treatment was extracted from the study database. Results: The annual exacerbation rate was 0.351 and 0.437 in the BDP/FF/G and IND/GLY arms respectively (adjusted rate ratio [95% CI] 0.803 [0.659, 0.978], p=0.029) for events subsequently treated with systemic steroids (with or without antibiotics and/or hospitalization). In case of events subsequently treated with antibiotics, the annual exacerbation rate was 0.402 and 0.494 in the BDP/FF/G IND/GLY arms respectively (adjusted rate ratio [95% CI] 0.815 [0.681, 0.974], p=0.025). For events subsequently treated with both antibiotics and systemic corticosteroids, the annual exacerbation rate was 0.243 and 0.314 in the BDP/FF/G and IND/GLY arms (adjusted rate ratio [95% CI] 0.774 [0.620, 0.964], p=0.022). Conclusions: These data show that the superior efficacy of extrafine BDP/FF/G compared to IND/GLY in reducing exacerbations is maintained irrespective of the treatment (antibiotics and/or systemic steroids) patients received and, hence, confirming its superior clinical benefit.