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| Name | Class |
|---|---|
| Doris Duke Charitable Foundation | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone+zileuton placebo | Experimental | Pioglitazone 45 mg qD for 2 weeks plus Sugar pill q6hr for 5 days |
|
| Zileuton+pioglitazone placebo | Experimental | Sugar pill qD for 2 weeks plus Zileuton 600 mg q6hr for 5 days |
|
| Pioglitazone placebo+zileuton placebo | Sham Comparator | Sugar pill qD for 2 weeks plus Sugar pill q6hr for 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zileuton | Drug | 600 mg tablets po QID for 5 days prior to endotoxin, stopping 24 hours after endotoxin instillation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ki, measure of FDG uptake | 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. | Before and after endotoxin |
| Measure | Description | Time Frame |
|---|---|---|
| Bronchoalveolar lavage (BAL) fluid cell counts | Total and neutrophil cell counts obtained by bronchoalveolar lavage after endotoxin. | After endotoxin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Delphine L Chen, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University / Barnes Jewish Hospital | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29414995 | Derived | Chen DL, Huang HJ, Byers DE, Shifren A, Belikoff B, Engle JT, Arentson E, Kemp D, Phillips S, Scherrer DE, Fujiwara H, Spayd KJ, Brooks FJ, Pierce RA, Castro M, Isakow W. The peroxisome proliferator-activated receptor agonist pioglitazone and 5-lipoxygenase inhibitor zileuton have no effect on lung inflammation in healthy volunteers by positron emission tomography in a single-blind placebo-controlled cohort study. PLoS One. 2018 Feb 7;13(2):e0191783. doi: 10.1371/journal.pone.0191783. eCollection 2018. |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C063449 | zileuton |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| 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 |
|
|
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |