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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Washington University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Doris Duke Charitable Foundation
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01174056
First received: July 30, 2010
Last updated: July 28, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Lung Inflammation
Drug: Rosiglitazone
Drug: Zileuton
Drug: Rosiglitazone placebo
Drug: Zileuton placebo
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Noninvasive Quantification of the Pulmonary Anti-inflammatory Effect of Rosiglitazone

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Ki, measure of FDG uptake [ Time Frame: Before and after endotoxin ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Bronchoalveolar lavage (BAL) fluid cell counts [ Time Frame: After endotoxin ] [ Designated as safety issue: No ]
    Total and neutrophil cell counts obtained by bronchoalveolar lavage after endotoxin.


Estimated Enrollment: 29
Study Start Date: July 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rosiglitazone+placebo Drug: Rosiglitazone
4 mg tablets, 1 tablet po bid for 2 weeks prior to endotoxin instillation, stopping at 24 hours after endotoxin instillation. Tablets are over encapsulated with a size 00 capsule (Gallipot, Inc., St. Paul, MN) and cushioned with lactose for blinding purposes.
Other Name: Avandia
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.
Experimental: Zileuton+placebo Drug: Zileuton
600 mg tablets po QID for 5 days prior to endotoxin, stopping 24 hours after endotoxin instillation
Other Name: Zyflo
Drug: Rosiglitazone placebo
Lactose filled gelatin capsule, size 00, 1 tablet po bid x 2 weeks prior to endotoxin instillation until 24 hours after endotoxin.
Experimental: Rosiglitazone+zileuton Drug: Rosiglitazone
4 mg tablets, 1 tablet po bid for 2 weeks prior to endotoxin instillation, stopping at 24 hours after endotoxin instillation. Tablets are over encapsulated with a size 00 capsule (Gallipot, Inc., St. Paul, MN) and cushioned with lactose for blinding purposes.
Other Name: Avandia
Drug: Zileuton
600 mg tablets po QID for 5 days prior to endotoxin, stopping 24 hours after endotoxin instillation
Other Name: Zyflo
Sham Comparator: Placebo+placebo Drug: Rosiglitazone 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.

  Eligibility

Ages Eligible for Study:   19 Years to 44 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01174056

Contacts
Contact: Delphine Chen, MD (314) 362-7029 chend@mir.wustl.edu

Locations
United States, Missouri
Washington University / Barnes Jewish Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: Delphine Chen, MD    314-362-7029    chend@mir.wustl.edu   
Principal Investigator: Delphine Chen, MD         
Sponsors and Collaborators
Washington University School of Medicine
Doris Duke Charitable Foundation
Investigators
Principal Investigator: Delphine L Chen, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Delphine L. Chen, MD/Assistant Professor of Radiology, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01174056     History of Changes
Other Study ID Numbers: DDCF-2010060
Study First Received: July 30, 2010
Last Updated: July 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Lung inflammation
positron emission tomography
fluorodeoxyglucose
rosiglitazone
zileuton
lung anti-inflammatory therapy

Additional relevant MeSH terms:
Inflammation
Pneumonia
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Zileuton
Anti-Inflammatory Agents
Rosiglitazone
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Lipoxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Central Nervous System Agents
Hypoglycemic Agents

ClinicalTrials.gov processed this record on April 21, 2014