NCT04296318

COPD Exacerbation Alert System With urinE anaLysis Using the HEADSTART Device

Protocol for COPE-WEL Observational Validation Trial COPD Exacerbation Alert System With urinE anaLysis - Clinical Validation of the Headstart® Test System for Early Detection of Exacerbations in Moderate/Severe COPD Patients

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 86 (actual)
• Sponsor: Mologic Ltd · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: —

Summary

The Headstart Test system is an in vitro diagnostic test intended for self-testing for the detection of five biomarkers of infection in the urine of patients diagnosed with chronic obstructive pulmonary disease (COPD). Patient urine testing will be conducted daily to establish a patient baseline biomarker profile and provide ongoing monitoring for changes in the biomarker profile. Headstart results will be used as an aid in monitoring and early detection of pulmonary exacerbation.

Detailed description

Patients will be asked to collect and test a daily urine sample using a novel testing system (HeadStart Test system) in addition to answering questions abut their daily COPD symptoms for 6 months. In summary, this study aims to validate a novel non-invasive point of care (near-patient) testing system, to allow people with COPD to detect pulmonary exacerbations by measuring urinary biomarkers. If successful, we hope that this will provide patients with an easy to use device, which will empower patients and their caregivers to treat exacerbations at an earlier stage, with potential health and economic benefits.

Conditions

• COPD Exacerbation

Timeline

• Start date: 2019-11-19
• Primary completion: 2022-02-15
• Completion: 2022-07-24
• First posted: 2020-03-05
• Last updated: 2022-07-28

Locations

1 site across 1 country: United Kingdom