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

Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lung Inflammation

Intervention: Zileuton (Drug); Pioglitazone placebo (Drug); Zileuton placebo (Drug); Pioglitazone (Drug)

Phase: Phase 0

Status: Completed

Sponsored by: Washington University School of Medicine

Official(s) and/or principal investigator(s):
Delphine L Chen, MD, Principal Investigator, Affiliation: Washington University School of Medicine

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.

Clinical Details

Official title: Noninvasive Quantification of the Pulmonary Anti-inflammatory Effect of Rosiglitazone

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Primary outcome: Ki, measure of FDG uptake

Secondary outcome: Bronchoalveolar lavage (BAL) fluid cell counts

Eligibility

Minimum age: 19 Years. Maximum age: 44 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy man or woman, any race or ethnicity, age 19 - 44 years old

- Screening FEV1 and FVC > 90% of predicted

- Screening oxygen saturation by pulse oximetry >97% on room air

- Capable of lying still and supine within the PET/CT scanner for ~1. 5 hours

- Capable of following instructions for breathing protocol during CT portion of PET/CT

- Able and willing to give informed consent

- BMI < 35

Exclusion Criteria:

- Pregnancy (confirmed by qualitative urine hCG pregnancy test)

- Lactation

- Active menstruation

- History of cardiopulmonary disease

- Currently taking any prescription medications

- History of tobacco use or illicit drug use within the past year

- Presence of implanted electronic medical device

- Enrollment in another research study of an investigational drug

- Known allergy to rosiglitazone or zileuton

- Known allergy to both trimethoprim/sulfamethoxazole and amoxicillin

- Known allergy to drugs routinely used during bronchoscopy

- History of chronic active liver disease or acute liver disease within the past 3

months

- SGOT >47 IU/L, SGPT > 53 IU/L, or bilirubin > 1. 1 mg/dl

- Inability lie flat for 1. 5 hours for PET/CT scans or follow breathing protocol

instructions for the CT portion of the PET/CT

- Prior research-related radiation exposure within the past year such that

participation in this study would result in exposures that exceed the limits as defined by the FDA RDRC regulations (21 CFR 361. 1).

Locations and Contacts

Washington University / Barnes Jewish Hospital, St. Louis, Missouri 63110, United States
Additional Information

Starting date: July 2011
Last updated: April 22, 2014

Page last updated: August 23, 2015

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