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

Dartmouth Health

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Other: Adults - CFPE Treatment

Study type: Observational

Funder types: Other

Identifiers

NCT02188758

D14136

KL2TR001088 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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;
• 18<Age>65

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

Trial design

20 participants in 1 patient group

Adults - CFPE Treatment

Description:

Other: CF Pulmonary Exacerbation (CFPE) Treatment

Treatment:

Other: Adults - CFPE Treatment