Rationale Current GOLD strategy indicate that treatment with a triple combination should be
recommended only for patients in GOLD D group. However, group B includes a significant
proportion of symptomatic COPD patients at risk of exacerbation that may benefit from
this treatment. TRIBUTE was a 52-week randomized, parallel group, double-blind, active-controlled
study, where 1532 symptomatic COPD patients at risk of exacerbations were randomized
in a 1 : 1 ratio to extrafine beclometasone dipropionate, formoterol fumarate and
glycopyrronium (BDP/FF/G 87/5/9 µg), via pressurized metered dose inhaler (pMDI; two
inhalations twice daily) or once daily indacaterol and glycopyrronium (IND/GLY 85/43 µg)
dry powder inhaler (DPI). Treatment with extrafine BDP/FF/G significantly reduced
exacerbations, and improved lung function and quality of life compared to IND/GLY
in the overall population. We re-categorised the study population into current GOLD
groups and conducted a post-hoc analysis where the effect of triple therapy was evaluated
in the subgroup of GOLD B patients.
Methods Out of 1532 randomized patients, 969 (63.3%) were classified as B (CAT score ≥ 10
with 1 exacerbation not leading to hospitalization or emergency room admission in
the previous year) according to GOLD 2017 classification. Results: In GOLD B patients,
extrafine single inhaler triple therapy significantly reduced moderate/severe exacerbations
by 23% (adjusted rate ratio: 0.77, 95% CI: 0.61 to 0.96, p = 0.020), reduced SGRQ
total score by −2.16 points (95% CI: −3.23 to −1.08, p < 0.001) and resulted in a
28 mL increase in FEV over the 52-week treatment period (95% CI: 5 to 51, p = 0.014)
compared to IND/GLY. These findings are consistent with those observed in the overall
population.
Conclusions This post-hoc analysis confirms the superior clinical efficacy of extrafine BDP/FF/G
compared to IND/GLY and indicate that such beneficial effects can be extended also
to GOLD B patients with only one moderate exacerbation in the previous year.
