NCT04297709

Study of Urinary Predictors of Exacerbations by Biomarkers in Cystic Fibrosis

Study of Urinary Predictors of Exacerbations by Biomarkers in Cystic Fibrosis (SUPERB-CF)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 29 (actual)
• Sponsor: Mologic Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Study of Urinary Predictors of Exacerbations by Biomarkers in Cystic Fibrosis

Detailed description

People with cystic fibrosis (CF) are prone to chest infections (pulmonary exacerbations) and suffer premature death due to respiratory failure. Patients that experience more frequent pulmonary exacerbations have worse prognosis and early antibiotic treatment of pulmonary exacerbations is therefore one of the major goals of CF care. Antibiotic treatment is often currently delayed, since we rely on patients contacting the CF team when they develop worsening symptoms. We hypothesise that if we could allow patients to detect and receive treatment for early pulmonary exacerbations by measuring urinary biomarkers, this would minimise lung damage and result in improved clinical outcomes. In phase 1, 40 patients will be asked to collect daily urine samples, in addition to recording daily spirometry and a daily symptom score for 4 months. Phase 1 aims to identify the urinary biomarkers that are associated with CF pulmonary exacerbations. In phase 2, the same 40 patients will be asked to collect and test a daily urine sample using a novel testing device in addition to recording daily spirometry and a daily symptom score for 4 months. Phase 2 aims to validate the use of the urine testing device as a method of diagnosing early pulmonary exacerbations. In summary, this study aims to develop and validate a novel noninvasive point of care (near-patient) diagnostic testing system, to allow people with CF to diagnose early 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

• Cystic Fibrosis

Timeline

• Start date: 2018-02-01
• Primary completion: 2019-07-31
• Completion: 2019-07-31
• First posted: 2020-03-05
• Last updated: 2020-03-11

Locations

1 site across 1 country: United Kingdom