IL-17 Neutrophils in CF Lung Inflammation
Completed
Conditions studied: Cystic Fibrosis
In brief
The purpose of this study is to determine whether IL-17 polymorphonuclear leukocytes (PMNs) are central to the disease pathology in CF. This will be determined by demonstrating that IL-17 PMNs are present in the CF airway, correlate with lung function measures, and decrease in patients being treated with IV antibiotics for a pulmonary exacerbation.
Key facts
- Study ID
- NCT02025829
- Run by
- University Hospitals Cleveland Medical Center
- People needed
- 14
- Starts
- 2014-02-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2019-02-15
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- For Both Cohorts: ≥ 18 < 50 years of age
- For Both Cohorts: Must have a documented diagnosis of CF (positive sweat chloride ≥60 milliequivalents (mEq)/liter, by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations consistent with CF accompanied by one or more clinical features with the CF) phenotype
- For Both Cohorts: Chronically infected with P. aeruginosa defined by 2 positive cultures in the past year or 3 in the last two years
- For Both Cohorts: Ability to expectorate mucus
- For Both Cohorts: Ability to provide written informed consent
- For Clinically Stable Cohort: 4 subjects with one copy of G551D
- For Clinically Stable Cohort: 10 subjects who do not have G551D, they must have one copy of F508del
- For Clinically Stable Cohort: CF subjects must have a baseline FEV1 percent predicted > 50% (in the last year, obtained from medical record)
- For Clinically Stable Cohort: Clinically stable: free of any acute illness for >14 days
- For Clinically Stable Cohort: Must have performed spirometry for clinical purposes at that clinical visit
- For Clinically Stable Cohort: Must have a sputum culture sent to the clinical lab for clinical purposes at the time of the study visit
- For Clinically Stable Cohort: Have not been prescribed any new systemic antibiotics for the 14 days prior to enrollment
- For Exacerbation/IV Antibiotics Cohort: One copy of F508del
- For Exacerbation/IV Antibiotics Cohort: Must have a doctor defined pulmonary exacerbation requiring treatment with IV antibiotics
- For Exacerbation/IV Antibiotics Cohort: Must have performed spirometry for clinical purposes within 72 hours of initiating IV antibiotics and within 72 hours of completing IV antibiotics
- For Exacerbation/IV Antibiotics Cohort: Must have a sputum culture sent to the clinical lab for clinical purposes within 72 hours of admission
You may not qualify if…
- For Both Cohorts: Pregnancy (based on self-report)
- For Both Cohorts: Co-infection with Burkholderia cepacia complex organisms
- For Both Cohorts: Any condition that in the opinion of the subject or the subject's managing physician that would compromise that individuals ability to participate in these studies
- For Both Cohorts: Inability to tolerate the study procedures
Where it is running
- Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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