Clinical trial NCT04297709: Study of Urinary Predictors of Exacerbations by Biomarkers in Cystic Fibrosis
Official title: Study of Urinary Predictors of Exacerbations by Biomarkers in Cystic Fibrosis (SUPERB-CF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Lead sponsor: Mologic Ltd
Sponsor class: INDUSTRY
Collaborators: name: Heart of England NHS Foundation Trust
First posted: 2020-03-05
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with CF

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Confirmed CF diagnosis
* Aged \>18 years of age
* Patients able and willing to give informed consent
* Requirement for at least one course of intravenous antibiotics for a pulmonary exacerbation within the previous 3 months.

Exclusion Criteria:

* Patients not able or not willing to give informed consent
* Patients who are currently participating in another clinical trial (excluding observational studies)
* Pneumothorax or lung surgery within the previous 3 months, eye surgery (e.g. cataract operation) in the previous 4 weeks, or any other factor that prevents safe measurement of spirometry.

Primary outcomes:
measure: Measurement of biomarkers in the urine of CF patients to assess their potential for predicting exacerbations
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
Study officials:
affiliation: Heart of England NHS Foundation Trust
name: Edward F Nash, BSc
role: PRINCIPAL_INVESTIGATOR
References: