Viral Pathogenesis of Early Cystic Fibrosis Lung Disease



Status:Completed
Conditions:Pulmonary, Pulmonary, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:4/5/2017
Start Date:May 2013
End Date:December 1, 2016

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The purpose of this study is to test the hypothesis that early viral infections alter the
bacterial flora and inflammatory profile in the airway and accelerate progression of
pulmonary disease in infants with cystic fibrosis.

The proposed study is a unique international collaboration between three large CF research
centers. This proposal will determine the impact of early respiratory viral infections on
bacterial flora and inflammatory profiles in the CF airway as well as the impact of these
pathogens on clinical, physiologic and structural markers of disease.The proposed study is
designed to follow infants diagnosed with CF through newborn screening to determine the
effect of viral infections on the lower airway microbiome, clinical symptoms, pulmonary
function and structural changes during the first year of life. The proposed study will
measure lower airway inflammation and infection using BAL, oral swabs, and nasal swabs;
outcomes will be assessed through infant lung function testing, computerized tomography
scans of the chest, and pulmonary exacerbation rate.

Inclusion Criteria:

1. Diagnosis of CF by newborn screening, at least one clinical feature of CF, and
documented sweat chloride greater than 60 mEq/L by quantitative pilocarpine
iontophoresis or compatible genotype with two identifiable mutant CFTR alleles.

2. Less than 4 months of age at Screening Visit

3. Ability to comply with study visits and study procedures as judged by site
investigator.

Exclusion Criteria:

1. Intercurrent respiratory illness, defined as increase in cough, wheezing, or
respiratory rate with onset 14 days before iPFT-bronchoscopy visit.

2. Measured hemoglobin oxygen saturation less than 95% during the iPFT-bronchoscopy
visit.

3. History of adverse reaction to sedation.

4. Clinically significant upper airway obstruction as determined by the site
investigator.

5. Severe gastroesophageal reflux, defined as persistent frequent emesis despite
therapy.

6. Major organ dysfunction, not including pancreatic dysfunction.

7. Physical findings that would compromise the safety of the subject or the quality of
the study data as determined by site investigator.
We found this trial at
3
sites
St. Louis, Missouri 63108
Principal Investigator: Thomas Ferkol, MD
Phone: 314-454-2353
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Indianapolis, Indiana 46202
Principal Investigator: Stephanie D Davis, MD
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Indianapolis, IN
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Melbourne, Victoria 3051
Principal Investigator: Sarath Ranganathan, MD
Phone: +011-61-3-9345-5843
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Melbourne,
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