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Keep this study
Lead
Vertex Pharmaceuticals Incorporated
With
Cystic Fibrosis Foundation
Currently, limited objective measures are available to quantify lung function in CF patients with mild lung disease. Lung clearance index (LCI) derived from inert gas multiple-breath washout (MBW) testing hold considerable promise to evaluate early lung disease as studies have detected abnormalities in a high percentage of CF patients with normal spirometry in both infants and children.
This study explored the effect of ivacaftor on LCI and the efficacy of ivacaftor on other clinical and biomarker endpoints of CF lung disease in subjects aged 6 years and older with CF who have the G551D-CFTR mutation on at least 1 allele.
Age
6–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female subjects with confirmed diagnosis of CF
Must have the G551D-CFTR mutation in at least 1 allele
FEV1 \>90% of predicted normal for age, gender, and height
You may not be if
Ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within the 30 days prior to screening
Use of inhaled hypertonic saline treatment within 2 weeks of the Period 1, Day 1 visit
Clareo Health | Study of the Effect of Ivacaftor on Lung Clearance Index in Subjects With Cystic Fibrosis and the G551D Mutation
