Changes in urinary biomarkers between stable state and exacerbation of COPD

Introduction: COPD exacerbations cause considerable morbidity and mortality. Simple near-patient tests that might provide early identification of COPD exacerbations are required. We sought to identify a panel of urinary biomarkers that can distinguish stable and exacerbation events retrospectively and prospectively. Methods: A panel of 50 urinary biomarkers were studied retrospectively from 55 COPD subjects. A panel of 10 biomarkers that could distinguish exacerbation and stable events was selected and developed as a near-patient dipstick test with a compact opto-electronic reader HEADSTART® (Mologic). This biomarker panel was validated in a prospective study of 105 COPD subjects recruited from 2 centres. Subjects undertook daily home urine testing over 6 months to explore the dynamic changes in the urine biomarker levels. We have undertaken an interim analysis of the exacerbation events captured in the first 6 months of the study to validate the biomarker panel at distinguishing between stable and exacerbation visits. Results: In the retrospective study the optimal 10 biomarkers were fibrinogen, fMLP, CC16, TIMP 1, TIMP 2, CRP, A1AT, B2M, MMP8, and NGAL. These showed a significant increase from stable state to exacerbation (p Conclusion: We have identified a panel of 10 biomarkers that can distinguish between stable and exacerbation state. The clinical utility of these biomarkers needs to be tested in future trials.