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

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

doi:10.1183/23120541.00950-2020

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

ERJ Open Res. 2021 Jun 7;7(2):00950-2020. doi: 10.1183/23120541.00950-2020. eCollection 2021 Apr.

Authors

David M G Halpin¹, Sally Worsley², Afisi S Ismaila^{3

4}, Kai-Michael Beeh⁵, Dawn Midwinter⁶, Janwillem W H Kocks^{7

8

9}, Elaine Irving², Jose M Marin^{10

11}, Neil Martin^{12

13}, Maggie Tabberer¹⁴, Neil G Snowise^{12

15}, Chris Compton¹⁶

Affiliations

¹ University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK.
² GSK R&D, Stevenage, UK.
³ Value Evidence and Outcomes, GSK, Collegeville, PA, USA.
⁴ Dept of Health Research Methods Evidence and Impact, McMaster University, Hamilton, ON, Canada.
⁵ Insaf Respiratory Research Institute, Wiesbaden, Germany.
⁶ GSK R&D, Brentford, UK.
⁷ General Practitioners Research Institute, Groningen, The Netherlands.
⁸ University of Groningen, University Medical Center Groningen, GRIAC Research Institute, Groningen, The Netherlands.
⁹ Observational and Pragmatic Research Institute, Singapore.
¹⁰ University Hospital Miguel Servet, IIS Aragón and CIBERES, Zaragoza, Spain.
¹¹ CIBER Enfermedades Respiratorias, Madrid, Spain.
¹² Global Medical Affairs, GSK, Brentford, UK.
¹³ Institute for Lung Health, University of Leicester, Leicester, UK.
¹⁴ Value Evidence and Outcomes, GSK, Brentford, UK.
¹⁵ Faculty of Life Sciences and Medicine, King's College London, London, UK.
¹⁶ Global Respiratory Franchise, GSK, Brentford, UK.

Abstract

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 (FF)/umeclidinium (UMEC)/vilanterol (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 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 (FEV₁) and percentage of patients making at least one 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 (OR 1.31, 95% CI 1.13-1.51; p<0.001) and mean change from baseline in FEV₁ was significantly greater with FF/UMEC/VI (77 mL versus 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.

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.