Respiratory medicine · 2025
TETRIS - Prospective study to observe clinical outcomes of triple therapy in COPD patients: Up to 12 months interim analysis.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Rohde Gernot, Vogelmeier Claus F, Beeh Kai-Michael, Kardos Peter, Paulsson Thomas, Watz Henrik, Westermayer Bernd, Mohan Tharishini, Noorduyn Stephen G, Claussen Jing
Аннотация
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.
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.
Предметные рубрики MeSH
AgedFemaleHumansMaleMiddle AgedAdministration, InhalationBenzyl AlcoholsBronchodilator AgentsBudesonideChlorobenzenesDrug Therapy, CombinationFollow-Up StudiesFormoterol FumarateGermanyGlycopyrrolateHospitalizationMuscarinic AntagonistsProspective StudiesPulmonary Disease, Chronic ObstructiveQuinuclidinesTreatment OutcomeAndrostadienes