Status:
COMPLETED
Biomarkers of Injury and Destruction in the Cystic Fibrosis Lung
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
National Institutes of Health (NIH)
Minnesota Medical Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6+ years
Brief Summary
Cystic fibrosis (CF) is the most common autosomal recessive genetic disease in Caucasians. It results in lung disease that affects quality of life and causes early death. Lung damage from CF starts in...
Detailed Description
This is a prospective, observational cohort study of two CF populations (and appropriate control populations): Infants with CF Diagnosed by Newborn Screen: The purpose of this prospective cohort stud...
Eligibility Criteria
Inclusion
- Infant Study Inclusion Criteria
- Age \< 6 months
- Cystic Fibrosis Diagnosed by Newborn Screen
- Exclusion:
- Age over 6months
- Child Study Inclusion Criteria
- FEV1 \< 35% predicted A
- Use of IV antibiotics for a pulmonary exacerbation or respiratory symptoms 12 months prior to enrollment.
- Hospitalization for a pulmonary exacerbation 12 months prior to enrollment.
- Use of oral antibiotic for respiratory symptoms 28 days prior to enrollment.
- Any changes in medical regimen for treatment of CF (e.g. no addition of or elimination of therapies such as hypertonic saline, inhaled corticosteroids or mucolytic therapy) within 28 days of enrollment visit.
- Exclusion Criteria:
- FEV1 \< 35% predicted A
- Use of IV antibiotics for a pulmonary exacerbation or respiratory symptoms 12 months prior to enrollment.
- Hospitalization for a pulmonary exacerbation 12 months prior to enrollment.
- Use of oral antibiotic for respiratory symptoms 28 days prior to enrollment.
- Any changes in medical regimen for treatment of CF (e.g. no addition of or elimination of therapies such as hypertonic saline, inhaled corticosteroids or mucolytic therapy) within 28 days of enrollment visit.
Exclusion
Key Trial Info
Start Date :
December 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01805713
Start Date
December 1 2012
End Date
December 1 2017
Last Update
January 12 2018
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455