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Report for Clinical Trial NCT01937325

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Airway Infection, Inflammatory Markers and Exercise Capacity in Patients With Cystic Fibrosis and at Least One G551D Mutation Taking VX770 (Ivacaftor)

Ivacaftor will restore CFTR function in treated CF patients with the G551D mutation. Improvement in ventilation, salt balance and well-being will contribute to better exercise capacity at all levels of lung function. While potential improvements may be variable across the spectrum of lung function, even small gains at low levels of FEV1 may have significant benefit for some subjects.

NCT01937325 Cystic Fibrosis
MeSH:Cystic Fibrosis Fibrosis

2 Interventions

Name: ivacaftor

Description: active arm
Type: Drug
Group Labels: 1

Ivacaftor

Name: placebo

Description: active arm
Type: Drug
Group Labels: 1

Placebo


Primary Outcomes

Description: Respiratory exercise testing, including spirometry and V02 max.

Measure: exercise capacity

Time: one month, 3 months

Secondary Outcomes

Description: Cytokine levels (IL-1β, IL-6, TNFα, IL-8, VEGF & Activin A) determined using cytometric bead analysis and / or ELISA

Measure: Inflammatory profile

Time: One month, 3 months

Purpose: Basic Science

Allocation: Randomized

Crossover Assignment


There is one SNP

SNPs


1 G551D

Airway Infection, Inflammatory Markers and Exercise Capacity in Patients With Cystic Fibrosis and at Least One G551D Mutation Taking VX770 (Ivacaftor). --- G551D ---

CPET in CF Patients With One G551D Mutation Taking VX770 Ivacaftor will restore CFTR function in treated CF patients with the G551D mutation. --- G551D ---

CPET in CF Patients With One G551D Mutation Taking VX770 Ivacaftor will restore CFTR function in treated CF patients with the G551D mutation. --- G551D --- --- G551D ---

- All participants will have at least one copy of the G551D mutation. --- G551D ---



HPO Nodes