Details

Autor(en) / Beteiligte

• Halpin, David M G
• Worsley, Sally
• Ismaila, Afisi S
• Beeh, Kai-Michael
• Midwinter, Dawn
• Kocks, Janwillem W H
• Irving, Elaine
• Marin, Jose M
• Martin, Neil
• Tabberer, Maggie
• Snowise, Neil G
• Compton, Chris

Titel

INTREPID: single- versus multiple-inhaler triple therapy for COPD in usual clinical practice

Ist Teil von

• ERJ open research, 2021-04, Vol.7 (2), p.950

Ort / Verlag

England: European Respiratory Society

Erscheinungsjahr

2021

Link zum Volltext

Quelle

EZB Electronic Journals Library

Beschreibungen/Notizen

• Real-world trial data comparing single- with multiple-inhaler triple therapy (MITT) in COPD patients are currently lacking. The effectiveness of once-daily single-inhaler fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) and MITT were compared in usual clinical care. INTREPID was a multicentre, randomised, open-label, phase IV effectiveness study comparing FF/UMEC/VI 100/62.5/25 µg the ELLIPTA inhaler with a clinician's choice of any approved non-ELLIPTA MITT in usual COPD clinical practice in five European countries. Primary end-point was proportion of COPD Assessment Test (CAT) responders (≥2-unit decrease in CAT score from baseline) at week 24. Secondary end-points in a subpopulation included change from baseline in forced expiratory volume in 1 s (FEV ) and percentage of patients making at least one critical error in inhalation technique at week 24. Safety was also assessed. 3092 patients were included (FF/UMEC/VI n=1545; MITT n=1547). The proportion of CAT responders at week 24 was significantly greater with FF/UMEC/VI non-ELLIPTA MITT (OR 1.31, 95% CI 1.13-1.51; p<0.001) and mean change from baseline in FEV was significantly greater with FF/UMEC/VI (77 mL 28 mL; treatment difference 50 mL, 95% CI 26-73 mL; p<0.001). The percentage of patients with at least one critical error in inhalation technique was low in both groups (FF/UMEC/VI 6%; non-ELLIPTA MITT 3%). Safety profiles, including incidence of pneumonia serious adverse events, were similar between treatments. In a usual clinical care setting, treatment with once-daily single-inhaler FF/UMEC/VI resulted in significantly more patients gaining health status improvement and greater lung function improvement non-ELLIPTA MITT.