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Targeting Oxidative Stress in Chronic Beryllium Disease

NCT01088243 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-10-12

Study results available
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Summary

The purpose of this study is to understand if a drug called mesalamine helps to control inflammation associated with chronic beryllium disease (CBD). We hypothesize that in CBD subjects treated with prednisone, mesalamine treatment will enhance the immunosuppressive effects of prednisone, and thus reduce the immune response to beryllium.

Conditions

  • Chronic Beryllium Disease

Interventions

DRUG

Mesalamine

Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.

DRUG

Placebo

Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.

Sponsors & Collaborators

  • National Jewish Health

    lead OTHER

Principal Investigators

  • Lisa A. Maier, M.D., MSPH · National Jewish Health

  • Brian Day, PhD · National Jewish Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01088243 on ClinicalTrials.gov