Conditions: Cystic Fibrosis
Keywords: digitoxin inflammatory markers cytokines gene expression
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 24
Healthy volunteers: no

Brief summary:
This study will measure the inflammatory effects of digitoxin on IL-8 and neutrophil counts in induced sputum in stable Cystic Fibrosis (CF) patients and the pharmacokinetics of digitoxin in serum.

Funding Source-FDA OOPD

Detailed description:
The study will be conducted as a randomized, double blind, placebo-controlled, repeat dosing trial evaluating the effects of 28 days of digitoxin on IL-8 and neutrophil concentrations in induced sputum in subjects with mild to moderate cystic fibrosis lung disease. Twenty-four total patients will be randomized into 3 groups of 8 subjects each (0.05 mg or 0.1 mg digitoxin or a placebo).

Arms:
arm 1: low dose 0.05mg digitoxin given once daily for 28 days arm 2: higher dose 0.1mg digitoxin daily for 28 days arm 3: placebo given daily for 28 days

Interventions: intervention 1: digitoxin intervention 2: digitoxin intervention 3: placebo
Intervention descriptions: intervention 1: 0.05mg tabs, once daily for 28 days intervention 2: 0.1mg pills, once daily for 28 days. intervention 3: pill taken once daily for 28 days

Protocol document: