A Phase 1 interventional study of Anakinra and Placebo in Healthy Control Subjects, sponsored by Michelle Hernandez, MD. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-07-15.
Sponsored by Michelle Hernandez, MD · Phase 1, Interventional, and Basic science
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.
1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.
This study's enrollment of 17 is below the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.
Browse Respiratory Aspiration studies →This is the only study on the registry with Michelle Hernandez, MD as lead sponsor.
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Exclusion Criteria:
All subjects will undergo 2 CCRE challenges. Each subject will be given either anakinra or placebo prior to CCRE challenge
Drug: Anakinra
Normal saline injection
Drug: Placebo
Active treatment will consist of 2 doses of 1 mg/kg up to 100 mg of anakinra SQ injection.
Injection of NS
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.
Time frame: 6 hours after inhalation of CCRE
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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