This trial is active, not recruiting.

Condition cystic fibrosis
Sponsor Indiana University School of Medicine
Collaborator National Institutes of Health (NIH)
Start date May 2013
End date December 2016
Trial size 90 participants
Trial identifier NCT01973192, 1R01HL116211-01


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Viral infection
time frame: 12 months

Secondary Outcomes

Pulmonary exacerbation rate
time frame: 12 Months
Forced Expiratory Volume
time frame: 12 months

Eligibility Criteria

Male or female participants from 2 months up to 4 months old.

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.

Additional Information

Official title Viral Pathogenesis of Early Cystic Fibrosis Lung Disease
Principal investigator Stephanie D. Davis, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Indiana University.