Rationale TRIBUTE study was a 52-week multicentre, randomised, double-blind, active-controlled study comparing twice daily fixed triple combination of extrafine beclometasone dipropionate, formoterol fumarate and glycopyrronium (BDP/FF/G 87/5/9 µg) via pressurized metered dose inhaler (pMDI) to once daily indacaterol and glycopyrronium (IND/GLY 85/43 µg) dry powder inhaler (DPI). 1532 COPD patients with a history of exacerbation in the previous 12 months and CAT total score ≥ 10 were randomized.
Methods The St George Respiratory questionnaire (SGRQ), a wellrecognized quality of life tool has been used to measure the impact on overall health, daily life, and perceived wellbeing in patients with COPD. The SGRQ total score was assessed as a secondary endpoint. We conducted post-hoc analyses considering the same stratifying factors used in pre-planned analyses for moderate/severe exacerbations and FEV.
Results In the overall population, the difference in the change from baseline in SGRQ total score between BDP/FF/G and IND/GLY was −1.68 (CI 95%: −2.55 to −0.81, p ≤ 0.001). This significant difference was confirmed also in the majority of the analysed subgroups, including patients with different disease severity or different levels of blood eosinophils.
Conclusions Twice daily extrafine BDP/FF/G improves quality of life of symptomatic patients with a history of exacerbations compared to once daily IND/GLY, independently of patient sub-classification.
