NCT Number: NCT02188758
The goal of this study is to identify chemical compounds in the blood and sputum (i.e., biomarkers) that are associated with objective measurements of health status in patients with cystic fibrosis (CF). This study builds upon observations that blood levels of hepcidin-25, a protein that regulates how the body uses and stores iron, vary during CF pulmonary exacerbation (CFPE).
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Notify Me18 year–65 year
All sexes
Observational
Maine Medical Center, South Portland, Maine, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(required at screening visit):
Exclusion criteria
Hospitalization for comprehensive treatment of CF pulmonary exacerbation, including intravenous (IV) antibiotics, nutritional assessment and support, airway clearance of mucus, use of inhaled mucolytic agents and bronchodilators, glycemic control with insulin, and psychosocial support.
Time frame: Duration of hospitalization, an expected average of 12 days
The primary endpoint of this study is the characterization of 3 groups (i.e., "low," "intermediate," and "high") of serum hepcidin-25 responders to CFPE treatment. Response will be defined as the ratio of post- to pre-treatment serum hepcidin-25 concentration for each subject.
Time frame: Duration of hospitalization, an expected average of 12 days
Post- to pre-treatment ratio for FEV1% for each subject.
Time frame: Duration of hospitalization, an expected average of 12 days
Post- to pre-treatment ratio for BMI for each subject.
Time frame: Duration of hospitalization, an expected average of 12 days
CFRSD-CRISS is a patient-reported outcome (PRO) instrument developed by the Seattle Quality of Life Group at the University of Washington and used herein under license to evaluate the severity of symptoms of CF in adults and adolescents (≥12 years) with a chronic respiratory infection. Symptoms assessed in the CFRSD-CRISS are: difficulty breathing, cough, cough up mucus, chest tightness, wheeze, feeling feverish, tired, and chills/sweats. The 8 items quantify symptom severity for the previous 24 hours to capture the magnitude of symptoms in stable CF, during medically treated CF exacerbations, and during recovery from an exacerbation. We will determine the within-subject differences in CFRSD-CRISS score associated with CFPE treatment.
Time frame: Duration of hospitalization, an expected average of 12 days
Post- to pre-treatment ratio for serum iron concentration for each subject.
Time frame: Duration of hospitalization, an expected average of 12 days
Post- to pre-treatment ratio for serum interleukin-6 (IL-6) concentration for each subject.
Time frame: Duration of hospitalization, an expected average of 12 days
Post- to pre-treatment ratio for sputum iron content for each subject.
Time frame: Duration of hospitalization, an expected average of 12 days
Post- to pre-treatment ratio for serum erythropoietin (EPO) for each subject.
Time frame: Duration of hospitalization, an expected average of 12 days
Post- to pre-treatment ratio for transferrin saturation for each subject.
Time frame: Duration of hospitalization, an expected average of 12 days
Post- to pre-treatment ratio for serum triggering receptor expressed on myeloid cells-1 (TREM-1) for each subject.
Time frame: Duration of hospitalization, an expected average of 12 days
Post- to pre-treatment ratio for serum soluble IL-6 receptor (sIL-6R) concentration for each subject.
Time frame: Duration of hospitalization, an expected average of 12 days
Post- to pre-treatment ratio for serum hemoglobin concentration for each subject.
Time frame: Duration of hospitalization, an expected average of 12 days
Post- to pre-treatment ratio for Simpson Diversity Index (SDI) for each subject.
Time frame: Duration of hospitalization, an expected average of 12 days
Post- to pre-treatment ratios for selected Pseudomonas aeruginosa mRNA transcript levels.
Time frame: Duration of hospitalization, an expected average of 12 days
Post- to pre-treatment ratios for selected mRNA transcript levels.
Dartmouth-Hitchcock Medical Center
Other
Do Changes in Serum Hepcidin-25 Concentration Predict Cystic Fibrosis Pulmonary Exacerbation (CFPE) Treatment Responses?
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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