Study of Urinary Predictors of Exacerbations by Biomarkers in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— SUPERB-CF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04297709
• Other study ID #: SUPERB-CF
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: March 2020
• Source: Mologic Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Study of Urinary Predictors of Exacerbations by Biomarkers in Cystic Fibrosis

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Locations

Country	Name	City	State
United Kingdom	Birmingham Heartlands Hospital	Birmingham

Sponsors (2)

Lead Sponsor	Collaborator
Mologic Ltd	Heart of England NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of biomarkers in the urine of CF patients to assess their potential for predicting exacerbations	Signalling molecules/acute phase proteins e.g. Interleukin 6 (IL-6), Interleukin 8 (IL-8), N-Formyl methionine Leucyl phenylalanine (fMLP), Fibrinogen, C-reactive protein (CRP).; Proteases & proteolytic activity, e.g. Matrix metalloproteases (MMP's), Myeloperoxidase (MPO), Human neutrophil elastase (HNE), Cathepsins.; Protease inhibitors, e.g. Tissue inhibitor of Metalloproteinase (TIMP), Alpha-1 anti-Trypsin (A1AT), Cystatin C, Secretory leukocyte peptidase inhibitor (SLPI).; Degradation products e.g. Desmosine and Elastin Fragments, Acetyl PGP (Ac-PGP).; Metabolites and other urinary markers, e.g. Creatinine, Human Serum Albumin (HSA), Retinol Binding Protein 4 (RBP4), Beta 2 Microglobulin (B2M).; Other markers of interest, e.g. Siglec 8, Chitinase 3 like 1 protein, Club cell protein 16 (CC16).; Note. Concentrations of all these biomarkers are expressed in microgramme/ml	4 months