N/A
N=14
IL-17 Neutrophils in CF Lung Inflammation
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT02025829 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Change in Sputum IL-17 Neutrophils — 55; 4 % of neutrophils positive for IL-17
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospitals Cleveland Medical Center
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Sputum IL-17 Neutrophils |
55; 4 | — |
| SECONDARY Sputum Inflammatory Mediators: IL-1β, IL-6, IL-8, IL-17A, TGF-β, TNF-α, and Neutrophil Elastase |
— | — |
| SECONDARY Sputum Inflammatory Mediators: IL-1β, IL-6, IL-8, IL-17A, and Neutrophil Elastase |
2313; 757; 53; 37; 5785; 3428 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- For Both Cohorts: ≥ 18 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02025829). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.