Status:
COMPLETED
Evaluation of Rosiglitazone Anti-inflammatory Effect With FDG-PET Imaging
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Doris Duke Charitable Foundation
Conditions:
Lung Inflammation
Eligibility:
All Genders
19-44 years
Phase:
EARLY_PHASE1
Brief 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 combinat...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01174056
Start Date
July 1 2011
End Date
March 1 2014
Last Update
April 23 2014
Active Locations (1)
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1
Washington University / Barnes Jewish Hospital
St Louis, Missouri, United States, 63110