Single Inhaler Extrafine Triple Therapy Improves Clinical Outcomes in Gold B COPD Patients: Post-Hoc Analysis of the TRIBUTE study

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.