Study of the Effect of Ivacaftor on Lung Clearance Index in Subjects With Cystic Fibrosis and the G551D Mutation

Completed · Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

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 at least 1 allele.

Key facts

Study ID

NCT01262352

Run by

Vertex Pharmaceuticals Incorporated

People needed

21

Starts

2011-01-01

Expected to finish

2011-11-01

Last updated by the study team

2013-02-11

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Study site — Stanford, California, United States
• Study site — Iowa City, Iowa, United States
• Study site — Durham, North Carolina, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Toronto, Ontario, Canada
• Study site — Belfast, United Kingdom
• Study site — Edinburgh, United Kingdom
• Study site — London, United Kingdom

Full record on ClinicalTrials.gov

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