Status:
COMPLETED
Biomarkers of Iron Homeostasis and Responses to Cystic Fibrosis Pulmonary Exacerbation (CFPE) Treatment
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
MaineHealth
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18-65 years
Brief Summary
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 (C...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02188758
Start Date
July 1 2014
End Date
January 1 2018
Last Update
March 13 2018
Active Locations (2)
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1
Maine Medical Center
South Portland, Maine, United States, 04106
2
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756