Biomarkers of Iron Homeostasis and Responses to Cystic Fibrosis Pulmonary Exacerbation (CFPE) Treatment

Status:	Completed
Conditions:	Pulmonary, Pulmonary
Therapuetic Areas:	Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	18 - 65
Updated:	4/17/2018
Start Date:	July 2014
End Date:	January 2018

Do Changes in Serum Hepcidin-25 Concentration Predict Cystic Fibrosis Pulmonary Exacerbation (CFPE) Treatment Responses?

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).

Inclusion Criteria (required at screening visit):

- Diagnosis of CF confirmed by history of positive chloride sweat test and/or CFTR
mutation analysis;

- History of consistent sputum production on most occasions;

- FEV1% greater than or equal to 75% of best measurement in previous 6 months;

- 1 or more hospitalizations for CFPE treatment with intravenous antibiotics within the
previous year;

- Absence of CFPE (i.e., Akron Pulmonary Exacerbation Score <5);

- Not admitted to hospital within the previous 3 weeks;

- Body weight greater than or equal to 75% of best measurement in previous 6 months;

- Provision of signed informed-consent to study protocol;

- 1865

Exclusion Criteria:

- Women who are pregnant or lactating;

- Subject does not meet Inclusion criteria;

- Recent and/or persistent visible blood in sputum (hemoptysis);

- Rescue use of oral antibiotics within the previous 3 weeks, defined as antibiotic use
for health deterioration rather than chronic suppression

We found this trial at

sites

Maine Medical Center

South Portland, Maine 04106

Principal Investigator: Jonathan B Zuckerman, M.D.

Phone: 207-828-1122

from

South Portland, ME