PT - JOURNAL ARTICLE AU - David M. G. Halpin AU - Sally Worsley AU - Afisi S. Ismaila AU - Kai-Michael Beeh AU - Dawn Midwinter AU - Janwillem W. H. Kocks AU - Elaine Irving AU - Jose M. Marin AU - Neil Martin AU - Maggie Tabberer AU - Neil G. Snowise AU - Chris Compton TI - INTREPID: single- <em>versus</em> multiple-inhaler triple therapy for COPD in usual clinical practice AID - 10.1183/23120541.00950-2020 DP - 2021 Jan 01 TA - ERJ Open Research PG - 00950-2020 4099 - http://openres.ersjournals.com/content/early/2021/03/26/23120541.00950-2020.short 4100 - http://openres.ersjournals.com/content/early/2021/03/26/23120541.00950-2020.full AB - Introduction 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/umeclidinium/vilanterol (FF/UMEC/VI) and MITT were compared in usual clinical care.Methods INTREPID was a multicentre, randomised, open-label, phase IV effectiveness study comparing FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA inhaler with a clinician's choice of any approved non-ELLIPTA MITT in usual COPD clinical practice in five European countries. Primary endpoint was proportion of COPD Assessment Test (CAT) responders (≥2-unit decrease in CAT score from baseline) at Week 24. Secondary endpoints in a subpopulation included change from baseline in forced expiratory volume in 1 s (FEV1) and percentage of patients making ≥1 critical error in inhalation technique at Week 24. Safety was also assessed.Results 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 versus non-ELLIPTA MITT (odds ratio: 1.31; 95% confidence interval [CI]: 1.13, 1.51; p&lt;0.001) and mean change from baseline in FEV1 was significantly greater with FF/UMEC/VI (77 mL versus 28 mL; treatment difference [95% CI] 50 mL [26, 73]; p&lt;0.001). The percentage of patients with ≥1 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.Conclusions 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 versus non-ELLIPTA MITT.FootnotesThis manuscript has recently been accepted for publication in the ERJ Open Research. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJOR online. Please open or download the PDF to view this article.Conflict of interest: D.M.G. Halpin reports reports this study was funded by GlaxoSmithKline (GSK) and medical writing support by Katie Baker at Fishawack Indicia Ltd, UK, was funded by GSK; and personal fees from AstraZeneca, personal fees and nonfinancial support from Boehringer Ingelheim, personal fees from Chiesi adn GSK, personal fees and nonfinancial support from Novartis, and personal fees from Pfizer and Sanofi, outside the submitted work.Conflict of interest: S. Worsley reports this study was funded by GlaxoSmithKline (GSK) and medical writing support by Katie Baker at Fishawack Indicia Ltd, UK, was funded by GSK, and S. Worsley is an employee of and holds shares/options in GSK.Conflict of interest: A.S. Ismaila reports this study was funded by GlaxoSmithKline (GSK) and medical writing support by Katie Baker at Fishawack Indicia Ltd, UK, was funded by GSK; and A.S. Ismaila is an employee of and holds shares/options in GSK, and is an unpaid, part-time professor at McMaster University.Conflict of interest: M. Beeh reports this study was funded by GlaxoSmithKline (GSK) and medical writing support by Katie Baker at Fishawack Indicia Ltd, UK, was funded by GSK; personal and/or institutional compensation for clinical research, consulting or lecturing fees from AstraZeneca, Boehringer Ingelheim, GSK, Novartis, Menarini/Berlin Chemie and Chiesi, consulting and lecturing fees from Sanofi and Elpen, and consulting fees from Sterna, outside the submitted work.Conflict of interest: D. Midwinter reports this study was funded by GlaxoSmithKline (GSK) and medical writing support by Katie Baker at Fishawack Indicia Ltd, UK, was funded by GSK, and D. Midwinter is an employee of and holds shares/options in GSK.Conflict of interest: J.W.H. Kocks reports this study was funded by GlaxoSmithKline (GSK) and medical writing support by Katie Baker at Fishawack Indicia Ltd, UK, was funded by GSK; and grants, personal fees and nonfinancial support from AstraZeneca, Boehringer Ingelheim and GlaxoSmithKline, grants and personal fees from Chiesi Pharmaceuticals and Novartis, and grants from MundiPharma and TEVA, outside the submitted work.Conflict of interest: E. Irving reports this study was funded by GlaxoSmithKline (GSK) and medical writing support by Katie Baker at Fishawack Indicia Ltd, UK, was funded by GSK, and E. Irving is an employee of and holds shares/options in GSK.Conflict of interest: J.M. Marin rreports this study was funded by GlaxoSmithKline (GSK) and medical writing support by Katie Baker at Fishawack Indicia Ltd, UK, was funded by GSK; and speaker fees from AstraZeneca, speaker fees from and membership of an advisory committee for GSK, and speaker fees from Chiesi and Menarini, outside the submitted work.Conflict of interest: N. Martin reports this study was funded by GlaxoSmithKline (GSK) and medical writing support by Katie Baker at Fishawack Indicia Ltd, UK, was funded by GSK, and N. Martin is an employee of and holds shares/options in GSK.Conflict of interest: Ms. Tabberer is an employee of and holds stock in GlaxoSmithKlineConflict of interest: N.G. Snowise reports this study was funded by GlaxoSmithKline (GSK) and medical writing support by Katie Baker at Fishawack Indicia Ltd, UK, was funded by GSK; and N.G. Snowise is a former employee of and holds shares/options in GSK, a shareholder in Vectura, and a visiting senior lecture at King's College London.Conflict of interest: C. Compton rreports this study was funded by GlaxoSmithKline (GSK) and medical writing support by Katie Baker at Fishawack Indicia Ltd, UK, was funded by GSK, and C. Compton is an employee of and holds shares/options in GSK.