A multicentre, observational prospective study to characterise the use of inhaled triple therapy for COPD: TETRIS final results after a 24-month follow-up period.

BackgroundChronic obstructive pulmonary disease (COPD) is a global health concern, characterised by exacerbations, worsening outcomes and increasing costs. Real-world studies are essential for understanding treatment regimens and long-term outcomes.ObjectiveTETRIS focused on the impact of triple therapy in managing COPD.Trial DesignTETRIS was a prospective, observational study that enrolled 1,196 patients with COPD from 134 centres who were on triple therapy for at least 2-48 weeks prior to inclusion.MethodsThe primary objectives were to quantify the proportion of patients continuously receiving triple therapy at 6, 12 and 24 months and assess time to discontinuation using Kaplan-Meier methodology. Clinical outcomes and therapy changes were evaluated overall and in subgroups by dosing regimen (once-daily [OD] vs. twice-daily [BID]) and specific single-inhaler triple therapies.ResultsPersistence with triple therapy was 92.5%, 84.4% and 38.5% at 6, 12 and 24 months, respectively. Only 10% of patients changed therapy over 24 months. At 24 months, the mean change in CAT sum score since baseline was -4.4 among patients on OD triple therapy (FF/UMEC/VI OD). The overall CAT responder rate was 50.1%. Exacerbation and hospitalisation rates remained low throughout the study. The composite endpoint of clinically important deterioration occurred in 53.6% of patients, with lower rates of 45.9% among patients receiving FF/UMEC/VI OD.ConclusionIn this real-world cohort, 38.5% of patients remained on triple therapy at 24 months, and most patients did not require a change in their initial therapy. The steep drop at 24 months was mostly because only few patients remained under observation since the protocol permitted study completion at 18 months, and any patient who dropped out from the study was not censored but counted as patient no longer on continuous triple therapy. These findings support the effectiveness and stability of triple therapy in routine practice and highlight the value of OD single-inhaler regimens in optimising COPD management.Registrationhttps://clinicaltrials.gov/study/NCT04657211.