INTREPID: Investigation of TRELEGY Effectiveness: Usual Practice Design
Summary
The primary purpose of this study is to assess the effectiveness of TRELEGY ELLIPTA relative to non-ELLIPTA Multiple Inhaler Triple Therapies (MITT) for Chronic Obstructive Pulmonary Disease (COPD) control within the usual clinical practice setting. The study will be conducted once TRELEGY ELLIPTA has been approved in the countries in which the study will be conducted and is available commercially. This is a randomized, open-label, effectiveness, phase 4 study of 24 weeks' duration in COPD subjects to evaluate TRELEGY ELLIPTA (fluticasone furoate \[FF\]/vilanterol \[VI\]/umeclidinium bromide \[UMEC\]: 100 microgram \[mcg\]/62.5 mcg/25 mcg) inhalation powder taken once daily using a single ELLIPTA inhaler compared with any non-ELLIPTA MITT in the usual care setting. Effectiveness of TRELEGY ELLIPTA will be assessed by comparing proportion of COPD Assessment Test (CAT) responders at Week 24 between two treatment groups. TRELEGY and ELLIPTA are trademarks of GlaxoSmithKline (GSK) group of companies. The study will enroll approximately 3000 subjects.
Timeline
- Start
- 2018-04-11
- Primary completion
- 2019-10-10
- Completion
- 2019-10-10
Outcome
Met primary endpoint
registry analysis (superiority test); FF /UMEC/VI: 100 mcg/62.5 mcg/25 mcg by ELLIPTA DPI vs Non-ELLIPTA MITT; p <0.001 NCT03467425 ↗
registry Odds Ratio (OR) 1.31 (95% CI 1.13 to 1.51) NCT03467425 ↗
Publications
- Beeh KM, Claussen J, Shah D, Martin A, Kendall R, Dasari P, Ismaila AS, Noorduyn SG. Cost-Effectiveness of Single-Inhaler Versus Multiple-Inhaler Triple Therapy in COPD: A German Healthcare Perspective. Int J Chron Obstruct Pulmon Dis. 2025 Jun 19;20:2011-2022. doi: 10.2147/COPD.S492524. eCollection 2025.
- Worsley S, Snowise N, Halpin DMG, Midwinter D, Ismaila AS, Irving E, Sansbury L, Tabberer M, Leather D, Compton C. Clinical effectiveness of once-daily fluticasone furoate/umeclidinium/vilanterol in usual practice: the COPD INTREPID study design. ERJ Open Res. 2019 Nov 4;5(4):00061-2019. doi: 10.1183/23120541.00061-2019. eCollection 2019 Oct.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluticasone Furoate | Other / unclassified | 100 ug | Inhaled |
| Subject | Umeclidinium | Other / unclassified | 62.5 ug | Inhaled |
| Subject | Vilanterol | Other / unclassified | 25 ug | Inhaled |