Evaluation of Rosiglitazone Anti-inflammatory Effect With FDG-PET Imaging
Noninvasive Quantification of the Pulmonary Anti-inflammatory Effect of Rosiglitazone
1 other identifier
interventional
39
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Jul 2011
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2010
CompletedFirst Posted
Study publicly available on registry
August 3, 2010
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedApril 23, 2014
April 1, 2014
2.7 years
July 30, 2010
April 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ki, measure of FDG uptake
Ki will be measured before and after endotoxin. Primary outcome measure is change in Ki (post- minus pre-endotoxin value) and absolute Ki after endotoxin.
Before and after endotoxin
Secondary Outcomes (1)
Bronchoalveolar lavage (BAL) fluid cell counts
After endotoxin
Study Arms (3)
Pioglitazone+zileuton placebo
EXPERIMENTALPioglitazone 45 mg qD for 2 weeks plus Sugar pill q6hr for 5 days
Zileuton+pioglitazone placebo
EXPERIMENTALSugar pill qD for 2 weeks plus Zileuton 600 mg q6hr for 5 days
Pioglitazone placebo+zileuton placebo
SHAM COMPARATORSugar pill qD for 2 weeks plus Sugar pill q6hr for 5 days
Interventions
600 mg tablets po QID for 5 days prior to endotoxin, stopping 24 hours after endotoxin instillation
Lactose filled gelatin capsule, size 00, 1 tablet po bid x 2 weeks prior to endotoxin instillation until 24 hours after endotoxin.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University / Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
Related Publications (1)
Chen DL, Huang HJ, Byers DE, Shifren A, Belikoff B, Engle JT, Arentson E, Kemp D, Phillips S, Scherrer DE, Fujiwara H, Spayd KJ, Brooks FJ, Pierce RA, Castro M, Isakow W. The peroxisome proliferator-activated receptor agonist pioglitazone and 5-lipoxygenase inhibitor zileuton have no effect on lung inflammation in healthy volunteers by positron emission tomography in a single-blind placebo-controlled cohort study. PLoS One. 2018 Feb 7;13(2):e0191783. doi: 10.1371/journal.pone.0191783. eCollection 2018.
PMID: 29414995DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Delphine L Chen, MD
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2010
First Posted
August 3, 2010
Study Start
July 1, 2011
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
April 23, 2014
Record last verified: 2014-04