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

This study has been completed.
Sponsor:
Collaborator:
Doris Duke Charitable Foundation
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01174056
First received: July 30, 2010
Last updated: April 22, 2014
Last verified: April 2014
  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: Zileuton
Drug: Pioglitazone placebo
Drug: Zileuton placebo
Drug: Pioglitazone
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.


Enrollment: 39
Study Start Date: July 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pioglitazone+zileuton placebo
Pioglitazone 45 mg qD for 2 weeks plus Sugar pill q6hr for 5 days
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
Other Name: Actos
Experimental: Zileuton+pioglitazone placebo
Sugar pill qD for 2 weeks plus Zileuton 600 mg q6hr for 5 days
Drug: Zileuton
600 mg tablets po QID for 5 days prior to endotoxin, stopping 24 hours after endotoxin instillation
Other Name: Zyflo
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.
Sham Comparator: Pioglitazone placebo+zileuton placebo
Sugar pill qD for 2 weeks plus Sugar pill q6hr for 5 days
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174056

Locations
United States, Missouri
Washington University / Barnes Jewish Hospital
St. Louis, Missouri, United States, 63110
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: 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: April 22, 2014
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
Pathologic Processes
Anti-Inflammatory Agents
Pioglitazone
Rosiglitazone
Zileuton
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Enzyme Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Leukotriene Antagonists
Lipoxygenase Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014