Quantifying Airway Inflammation With Radiologic Tests
Imaging Biomarkers of Pulmonary Inflammation
調査の概要
状態
条件
詳細な説明
研究の種類
入学 (実際)
段階
- 初期フェーズ 1
連絡先と場所
研究場所
-
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Missouri
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Saint Louis、Missouri、アメリカ、63110
- Washington University School of Medicine
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Healthy, man or woman, any race or ethnicity, age 19 - 44 years old
- Screening FEV1 and FVC must be > 80% of predicted.
- Screening oxygen saturation by pulse oximetry is >97% on room air.
- Research volunteer must be capable of lying still and supine within the PET scanner for ~2 ½ hours.
- Research volunteer must be capable of fasting for 6 hours.
Exclusion Criteria:
- Pregnancy (confirmed by a qualitative urine hCG pregnancy test)
- Lactation.
- Actively menstruating at time of randomization
- History of tobacco use or has smoked other illicit drugs (marijuana, cocaine) in the past year.
- Research volunteer is currently taking any prescription medications.
- Research volunteer is at increased risk for radiation exposure (e.g. flight attendants)
- Research volunteer is enrolled in another research study of an investigational drug.
- Research volunteer has a known allergy to both trimethoprim/sulfamethoxazole and amoxicillin.
- Research volunteer has a known allergy to drugs routinely used during bronchoscopy.
- Research volunteer has a known allergy to lovastatin or rhAPC
- Fasting glucose at time of PET study > 150 mg/dl.
Exclusion criteria related to use of rhAPC:
- Active or history of internal bleeding within the past 3 months
- History of hemorrhagic stroke within the past 3 months.
- History of intracranial or intraspinal surgery, or severe head trauma, within the past 3 months
- History of trauma with an increased risk of life-threatening bleeding within the past 3 months
- History of receiving thrombolytic therapy within the past 3 months.
- History of receiving oral anticoagulants or glycoprotein IIb/IIIa inhibitors within the past 3 months.
- History of using aspirin > 650 mg/d or other platelet inhibitors within the past 7 days.
- Any history of intracranial arteriovenous malformation or aneurysm
- Any history of a known bleeding diathesis
- Any history of chronic severe hepatic disease
- Presence of an epidural catheter
- Any history of intracranial neoplasm or mass lesion or evidence of cerebral herniation
- Use of heparin during past 7 days
- Platelet count <100,000 x 106/L
- Prothrombin time-INR > 1.5
- SGOT >47 IU/L, SGPT > 53 IU/L, or bilirubin > 1.1 mg/dl
- Any other condition in which bleeding constitutes a significant hazard or would be particularly difficult to manage because of its location.
Exclusion criteria related to use of lovastatin:
- 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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター:Placebo pill and placebo IV
|
Placebo pill every four hours, starting 16 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS Placebo IV starting 2 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS
Endotoxin 4 ng/kg instilled bronchoscopically in all volunteers 12 hours after starting lovastatin treatment and 2 hours after starting recombinant human activated protein C treatment.
他の名前:
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実験的:Lovastatin pill and placebo IV
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Endotoxin 4 ng/kg instilled bronchoscopically in all volunteers 12 hours after starting lovastatin treatment and 2 hours after starting recombinant human activated protein C treatment.
他の名前:
lovastatin pill every four hours, total of 80 milligrams a day, starting 16 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS Placebo IV starting 2 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS
他の名前:
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実験的:Placebo pill and rhAPC IV
|
Endotoxin 4 ng/kg instilled bronchoscopically in all volunteers 12 hours after starting lovastatin treatment and 2 hours after starting recombinant human activated protein C treatment.
他の名前:
placebo pill every four hours, total of 80 milligrams a day, starting 16 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS recombinant human activated protein C IV 24 micrograms per kg per hour starting 2 hours before intrabronchial LPS and ending 24 hours after intrabronchial LPS
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Ki (Measure of [18F]Fluorodeoxyglucose ([18F]FDG) Uptake Determined by Patlak Graphical Analysis) in the Right Lung 24 Hours After LPS Instillation
時間枠:24 hours after endotoxin instillation
|
Calculated Ki was used to measure the amount of lung inflammation before and after instillation of endotoxin to assess the effect of placebo, lovastatin, and rhAPC treatment
|
24 hours after endotoxin instillation
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Total Nucleated Cells From Bronchoalveolar Lavage (BAL) Fluid 24 Hours After Endotoxin Instillation
時間枠:24 hours after endotoxin instillation
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Number of total nucleated cells isolated from the first aliquoe of BAL obtained to correlate with PET data.
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24 hours after endotoxin instillation
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協力者と研究者
捜査官
- 主任研究者:Delphine L Chen, MD、Washington University School of Medicine
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 05-1137
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