Viral Pathogenesis of Early Cystic Fibrosis Lung Disease

Completed

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT01973192

Run by

Indiana University

People needed

65

Starts

2013-05-01

Expected to finish

2016-12-01

Last updated by the study team

2017-04-04

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Less than 4 months of age at Screening Visit
• Ability to comply with study visits and study procedures as judged by site investigator.

You may not qualify if…

• Intercurrent respiratory illness, defined as increase in cough, wheezing, or respiratory rate with onset 14 days before iPFT-bronchoscopy visit.
• Measured hemoglobin oxygen saturation less than 95% during the iPFT-bronchoscopy visit.
• History of adverse reaction to sedation.
• Clinically significant upper airway obstruction as determined by the site investigator.
• Severe gastroesophageal reflux, defined as persistent frequent emesis despite therapy.
• Major organ dysfunction, not including pancreatic dysfunction.
• Physical findings that would compromise the safety of the subject or the quality of the study data as determined by site investigator.

Where it is running

• Riley Hospital for Children at Indiana University Health — Indianapolis, Indiana, United States
• St. Louis Children's Hospital — St Louis, Missouri, United States
• The Royal Children's Hospital — Melbourne, Victoria, Australia
• Telethon Kids Institute — West Perth, Australia

Full record on ClinicalTrials.gov

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