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

Overview

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.

Full Title of Study: “Noninvasive Quantification of the Pulmonary Anti-inflammatory Effect of Rosiglitazone”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Basic Science
    • Masking: Single (Participant)
  • Study Primary Completion Date: March 2014

Interventions

  • Drug: Zileuton
    • 600 mg tablets po QID for 5 days prior to endotoxin, stopping 24 hours after endotoxin instillation
  • Drug: Pioglitazone placebo
    • Lactose filled gelatin capsule, size 00, 1 tablet po bid x 2 weeks prior to endotoxin instillation until 24 hours after endotoxin.
  • Drug: Zileuton placebo
    • 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.
  • Drug: Pioglitazone
    • PPAR-gamma agonist

Arms, Groups and Cohorts

  • Experimental: Pioglitazone+zileuton placebo
    • Pioglitazone 45 mg qD for 2 weeks plus Sugar pill q6hr for 5 days
  • Experimental: Zileuton+pioglitazone placebo
    • Sugar pill qD for 2 weeks plus Zileuton 600 mg q6hr for 5 days
  • Sham Comparator: Pioglitazone placebo+zileuton placebo
    • Sugar pill qD for 2 weeks plus Sugar pill q6hr for 5 days

Clinical Trial Outcome Measures

Primary Measures

  • Ki, measure of FDG uptake
    • Time Frame: Before and after endotoxin
    • 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.

Secondary Measures

  • Bronchoalveolar lavage (BAL) fluid cell counts
    • Time Frame: After endotoxin
    • Total and neutrophil cell counts obtained by bronchoalveolar lavage after endotoxin.

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 44 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Washington University School of Medicine
  • Collaborator
    • Doris Duke Charitable Foundation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Delphine L Chen, MD, Principal Investigator, Washington University School of Medicine

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