TETRIS - Prospective study to observe clinical outcomes of triple therapy in COPD patients: Up to 12 months interim analysis.

BACKGROUND

Real-world cohorts provide a more universal understanding of the factors influencing treatment decision outcomes in patients with chronic obstructive pulmonary disease (COPD).

METHODS

The objective of the TETRIS study is to elucidate influences on treatment decisions surrounding triple therapy (TT) in COPD patients over a 2-year follow-up period in a real-world setting in Germany. TETRIS included 1217 patients with COPD with/without asthma, already on TT for 2-48 weeks. Here, we report interim analyses of clinical endpoints at the 6-month and 1-year follow-up visits in subgroups of patients (n = 840) stratified based on single versus multiple-inhaler TT (SITT versus MITT), once versus twice-daily TT (OD versus BID) and different SITTs the patients were currently on.

RESULTS

Mean number of hospitalisations due to exacerbations was significantly lower among the subgroup on fluticasone furoate, umeclidinium, and vilanterol administered OD (FF/UMEC/VI OD) versus budesonide, glycopyrrolate, and formoterol fumarate administered BID (BUD/GLY/FOR BID) subgroup at 6 months and 1-year (both, p < 0.0001) as well as among OD versus BID TT subgroups at 1-year (p = 0.02). The change in mean COPD assessment test sum score was significantly greater in the SITT versus MITT and OD versus BID TT subgroups at 6 months (p = 0.0018 and p = 0.0202, respectively) and 1-year (p = 0.0071 and p = 0.0002, respectively), and in the FF/UMEC/VI OD versus BUD/GLY/FOR BID subgroup at 1-year (p = 0.0004).

CONCLUSION

Overall, SITT dosed OD, specifically FF/UMEC/VI is associated with a significant reduction in hospitalisations due to exacerbations and improvement in symptoms at the 6-month and 1-year follow-up visits.

REGISTRATION: https://clinicaltrials.gov/study/NCT04657211.