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

NCT01262352 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2013-02-11

Study results available
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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 at least 1 allele.

Conditions

Interventions

DRUG

Ivacaftor

150 mg tablet, oral use, twice daily every 12 hours (q12h)

DRUG

Placebo

Tablet, oral use, twice daily every 12 hours (q12h)

Sponsors & Collaborators

Principal Investigators

  • Jane Davies · Royal Brompton Hospital and Imperial College

  • Felix Ratjen · The Hospital for Sick Children

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United States
  • Canada
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01262352 on ClinicalTrials.gov