Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT04296318
Brief 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.
Study:
NCT04296318
Study Brief:
Protocol Section:
NCT04296318