NCT00782288

Phase II Study of Digitoxin to Treat Cystic Fibrosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: National Jewish Health · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	digitoxin	0.05mg tabs, once daily for 28 days
DRUG	digitoxin	0.1mg pills, once daily for 28 days.
OTHER	placebo	pill taken once daily for 28 days

Timeline

• Start date: 2010-08-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2008-10-31
• Last updated: 2022-04-21
• Results posted: 2016-01-22

Locations

1 site across 1 country: United States