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

The Washington University

Status and phase: Completed; Early Phase 1

Conditions: Lung Inflammation

Treatments: Drug: Pioglitazone placebo; Drug: Pioglitazone; Drug: Zileuton placebo; Drug: Zileuton

Study type: Interventional

Funder types: Other

Identifiers

NCT01174056

DDCF-2010060

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 19 to 44 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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39 participants in 3 patient groups

Pioglitazone+zileuton placebo

Experimental group

Description:

Pioglitazone 45 mg qD for 2 weeks plus Sugar pill q6hr for 5 days

Treatment:

Drug: Zileuton placebo

Drug: Pioglitazone

Zileuton+pioglitazone placebo

Experimental group

Description:

Sugar pill qD for 2 weeks plus Zileuton 600 mg q6hr for 5 days

Treatment:

Drug: Zileuton

Drug: Pioglitazone placebo

Pioglitazone placebo+zileuton placebo

Sham Comparator group

Description:

Sugar pill qD for 2 weeks plus Sugar pill q6hr for 5 days

Treatment:

Drug: Zileuton placebo

Drug: Pioglitazone placebo