Evaluation of Rosiglitazone Anti-inflammatory Effect With FDG-PET Imaging
| Status: | Completed |
|---|---|
| Conditions: | Pneumonia |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 19 - 44 |
| Updated: | 5/3/2014 |
| Start Date: | July 2011 |
| End Date: | July 2013 |
| Contact: | Delphine Chen, MD |
| Email: | chend@mir.wustl.edu |
| Phone: | (314) 362-7029 |
Noninvasive Quantification of the Pulmonary Anti-inflammatory Effect of Rosiglitazone
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.
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.
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).
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