Phase II Study of Digitoxin to Treat Cystic Fibrosis

NCT00782288 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-04-21

Study results available
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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

Conditions

Interventions

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

Sponsors & Collaborators

  • National Jewish Health

    lead OTHER

Principal Investigators

  • Pamela L Zeitlin, MD, PhD · Johns Hopkins University, School of Medicine, Pediatric Pulmonary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00782288 on ClinicalTrials.gov