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Completed

NCT Number: NCT01174056

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

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.

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Key information

Conditions

Lung Inflammation Infections Lung Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

19 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Washington University / Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

zileuton

Drug

600 mg tablets po QID for 5 days prior to endotoxin, stopping 24 hours after endotoxin instillation

Other names: Zyflo

Pioglitazone placebo

Drug

Lactose filled gelatin capsule, size 00, 1 tablet po bid x 2 weeks prior to endotoxin instillation until 24 hours after endotoxin.

Zileuton placebo

Drug

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.

pioglitazone

Drug

PPAR-gamma agonist

Other names: Actos

Primary outcomes

  1. 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 outcomes

  1. Bronchoalveolar lavage (BAL) fluid cell counts

    Time frame: After endotoxin

    Total and neutrophil cell counts obtained by bronchoalveolar lavage after endotoxin.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Doris Duke Charitable Foundation

Registry information

Official study title

Noninvasive Quantification of the Pulmonary Anti-inflammatory Effect of Rosiglitazone

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 3, 2010
Registry last updated
Apr 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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