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| ID | Type | Description | Link |
|---|---|---|---|
| 1U19AI077437-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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The investigators want to see if healthy people who are given 2 doses of a medication called anakinra, which is used to treat moderate to severe rheumatoid arthritis, (RA) and then exposed to a form of air pollution, called Endotoxin, have less inflammation with the medication. Endotoxin is believed to be one of the causes of asthma attacks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anakinra | Active Comparator | All subjects will undergo 2 CCRE challenges. Each subject will be given either anakinra or placebo prior to CCRE challenge |
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| Placebo | Placebo Comparator | Normal saline injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anakinra | Drug | Active treatment will consist of 2 doses of 1 mg/kg up to 100 mg of anakinra SQ injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| blockade of IL-1 β will suppress neutrophil response to challenge with 20,000 EU CCRE | The primary endpoints for this study will be a) safety assessments of anakinra with CCRE inhalation and b) the post CCRE challenge percentage of neutrophils (%PMN) in airway sputum during the anakinra treatment period compared to the placebo treatment period. | 6 hours after inhalation of CCRE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Hernandez, MD | UNC CH SOM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Center for Environmental Medicine, Asthma and Lung Biology | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Term |
|---|---|
| D053590 | Interleukin 1 Receptor Antagonist Protein |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Placebo | Drug | Injection of NS |
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| D011506 | Proteins |
| D001685 | Biological Factors |