CFF Biomarkers of Exacerbation

Therapuetic Areas:Pulmonary / Respiratory Diseases
Age Range:Any
Start Date:December 2007
Contact:Scott D Sagel, MD

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Multi-center Trial to Validate Protein Biomarkers of a Pulmonary Exacerbation in Cystic Fibrosis

Clinical and translational research in cystic fibrosis (CF) is hampered by a lack of
biomarkers that can be used to identify promising new therapies. There is an urgent need for
development and validation of biomarkers that more quickly predict the usefulness of
potential drugs in CF and might prognosticate clinical course. In particular, combinations
of protein biomarkers that can be obtained non-invasively offer great promise. The goal of
this project is to determine whether protein biomarkers in blood can demonstrate a
beneficial effect of treatment over two weeks. We intend to initially target an acute
pulmonary exacerbation in CF because we know that subjects being treated with intravenous
antibiotics and enhanced mucus clearance display clinical improvements within two weeks. We
propose to prospectively collect blood samples from a large cohort of well-characterized CF
persons serially during inpatient admissions for a pulmonary exacerbation and longitudinally
during annual visits. Through this proposal, we hope to identify a CF lung injury biomarker
panel that increases in the setting of an acute pulmonary exacerbation and improves rapidly
following intravenous antibiotic therapy. Additionally, we will begin to explore whether
this CF lung injury biomarker panel might also prognosticate clinical course including
decline in pulmonary function. Finally, this study will serve as an important source of
blood samples that will be banked for future biomarker and therapeutic studies designed to
benefit the entire CF community.

Inclusion Criteria:

- Diagnosis of CF as evidenced by a sweat chloride test >60mEq/L or by the presence of
two known CF genetic mutations

- Male or female greater than or equal to 10 years of age

- Initiation of intravenous antibiotic therapy for a clinically diagnosed acute
pulmonary exacerbation

- Ability to perform reproducible pulmonary function tests

- Willing to comply with the study procedures and willingness to provide written

Exclusion Criteria:

- Presence of a condition or abnormality that, in the opinion of the Principal
Investigator (PI), would compromise the safety of the patient or quality of the data
We found this trial at
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
Nashville, TN
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
Ann Arbor, MI
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10900 Euclid Ave
Cleveland, Ohio 44106
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
Cleveland, OH
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Denver, CO
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
Indianapolis, IN
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