Noninvasive Quantification of the Pulmonary Anti-inflammatory Effect of Rosiglitazone
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Ki, measure of FDG uptake
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 44 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
Pioglitazone+zileuton placebo
Pioglitazone 45 mg qD for 2 weeks plus Sugar pill q6hr for 5 days
干预措施: Zileuton placebo (Drug)
Pioglitazone+zileuton placebo
Pioglitazone 45 mg qD for 2 weeks plus Sugar pill q6hr for 5 days
干预措施: Pioglitazone (Drug)
Zileuton+pioglitazone placebo
Sugar pill qD for 2 weeks plus Zileuton 600 mg q6hr for 5 days
干预措施: Zileuton (Drug)
Zileuton+pioglitazone placebo
Sugar pill qD for 2 weeks plus Zileuton 600 mg q6hr for 5 days
干预措施: Pioglitazone placebo (Drug)
Pioglitazone placebo+zileuton placebo
Sugar pill qD for 2 weeks plus Sugar pill q6hr for 5 days
干预措施: Pioglitazone placebo (Drug)
Pioglitazone placebo+zileuton placebo
Sugar pill qD for 2 weeks plus Sugar pill q6hr for 5 days
干预措施: Zileuton placebo (Drug)
结局指标
主要结局
Ki, measure of FDG uptake
时间窗: 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.
次要结局
- Bronchoalveolar lavage (BAL) fluid cell counts(After endotoxin)