N/A
Completed N=8
(Study: Vertex IIS) Does Ivacaftor Alter Wild Type CFTR-Open Probability In The Sweat Gland Secretory Coil?
Source: ClinicalTrials.gov NCT02310789 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcomePrimary: Change in Cystic Fibrosis Transmembrane Conductance Regulator (CFTR)-Dependent Sweat Rate — 16.45; 6.60 percent change
Summary
Clinical studies of lumacaftor + ivacaftor (combo therapy) produced better FEV1 (forced expiratory volume in 1 second) improvements than ivacaftor alone, without further improvement in sweat chloride results.
To help understand why sweat chloride was unresponsive, the investigators will use a newly developed sweat secretion test that provides accurate, in vivo readout of CFTR (cystic fibrosis transmembrane conductance regulator) function in the sweat gland secretory coil.
The investigators devised a protocol to determine if short courses of ivacaftor (3.5 days) will produce significant increases in WT (Wild-Type, i.e. normal) CFTR open probability by measuring CFTR-dependent sweating (C-sweat) in subjects with WT CFTR.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cystic Fibrosis Transmembrane Conductance Regulator (CFTR)-Dependent Sweat Rate |
16.45; 6.60 | — |
| SECONDARY Change Sweat Chloride Production |
25.1; 24.9 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy adults without a Cystic Fibrosis (CF) mutation
- Carriers with a known CF mutation
Exclusion Criteria
- Documented liver disease
- Participants should not be taking:
- medicines that are strong CYP3A (Cytochrome P450, family 3, subfamily A) inducers, such as:
- the antibiotics rifampin and rifabutin;
- seizure medications (phenobarbital, carbamazepine, or phenytoin); and
- the herbal supplement St. John's Wort, substantially decreases exposure of ivacaftor and may diminish effectiveness.
Data sourced from ClinicalTrials.gov (NCT02310789). 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.