Phase 2
Completed N=21
Study of the Effect of Ivacaftor on Lung Clearance Index in Subjects With Cystic Fibrosis and the G551D Mutation
Source: ClinicalTrials.gov NCT01262352 ↗Enrolled (actual)
21
Serious AEs
8.1%
Results posted
Jan 2013
Primary outcomePrimary: Absolute Change From Baseline in Lung Clearance Index (LCI) — 0.77; -1.30 ratio — p=0.0004
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in Lung Clearance Index (LCI) |
0.77; -1.30 | 0.0004 sig |
| SECONDARY Absolute Change From Baseline in Percent Predicted FEV1 |
0.00; 7.00 | 0.0117 sig |
| SECONDARY Change From Baseline in Sweat Chloride |
0.11; -45.74 | <0.0001 sig |
| SECONDARY Change From Baseline in CF Questionnaire-Revised (CFQ-R) Score (Respiratory Domain Score, Pooled) |
1.33; 5.32 | 0.3796 |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01262352). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.