Status:
COMPLETED
Study of the Effect of Ivacaftor on Lung Clearance Index in Subjects With Cystic Fibrosis and the G551D Mutation
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effect of ivacaftor (VX-770) on lung clearance index (LCI) in subjects aged 6 years and older with cystic fibrosis (CF) who have the G551D-CFTR mutation on...
Detailed Description
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) tes...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01262352
Start Date
January 1 2011
End Date
November 1 2011
Last Update
February 11 2013
Active Locations (8)
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1
Stanford, California, United States
2
Iowa City, Iowa, United States
3
Durham, North Carolina, United States
4
Pittsburgh, Pennsylvania, United States