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Evaluation of Rosiglitazone Anti-inflammatory Effect With FDG-PET Imaging

NCT01174056 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2014-04-23

No results posted yet for this study

Summary

The purpose of this research study is to gain understanding of the basic responses of the lung to inflammation and specifically if a certain medication can reduce the inflammation alone or in combination with another. Inflammation is the way our bodies react to irritation or injury, and involves red, warm, and often painful swelling of the affected tissue. "Acute lung injury" involves inflammation that is not specific to one area of the lung and is caused by any one of several conditions: infection, trauma, breathing toxic substances, etc. When lung injury is severe, not enough oxygen can get into the body; this can lead to the need for mechanical support of breathing (mechanical ventilation), problems with brain, heart or other organ function, and in some cases, death.

Conditions

  • Lung Inflammation

Interventions

DRUG

Zileuton

600 mg tablets po QID for 5 days prior to endotoxin, stopping 24 hours after endotoxin instillation

DRUG

Pioglitazone placebo

Lactose filled gelatin capsule, size 00, 1 tablet po bid x 2 weeks prior to endotoxin instillation until 24 hours after endotoxin.

DRUG

Zileuton placebo

Placebo tablets provided by manufacturer of Zyflo CR (Cornerstone Therapeutics), 2 tablets po bid x 5 days prior to endotoxin instillation until 24 hours after endotoxin.

DRUG

Pioglitazone

PPAR-gamma agonist

Sponsors & Collaborators

  • Doris Duke Charitable Foundation

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Delphine L Chen, MD · Washington University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
19 Years
Max Age
44 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

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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 NCT01174056 on ClinicalTrials.gov