Clinical trial NCT01174056: Evaluation of Rosiglitazone Anti-inflammatory Effect With FDG-PET Imaging
Official title: Noninvasive Quantification of the Pulmonary Anti-inflammatory Effect of Rosiglitazone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Lung Inflammation
Keywords: Lung inflammation
positron emission tomography
fluorodeoxyglucose
rosiglitazone
zileuton
lung anti-inflammatory therapy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Doris Duke Charitable Foundation
First posted: 2010-08-03
Enrollment: 39
Sex: ALL
Minimum age (years): 19
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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).

Primary outcomes:
measure: Ki, measure of FDG uptake
timeFrame: Before and after endotoxin
Secondary outcomes:
measure: Bronchoalveolar lavage (BAL) fluid cell counts
timeFrame: After endotoxin
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University / Barnes Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Delphine L Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.