Effect of Interleukin-1 Receptor Antagonist on Inhalation of 20,000 EU Clinical Ctr Reference Endotoxin in Normal Volunteers
NCT ID: NCT01369017
Last Updated: 2013-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
17 participants
INTERVENTIONAL
2011-10-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Anakinra
All subjects will undergo 2 CCRE challenges. Each subject will be given either anakinra or placebo prior to CCRE challenge
Anakinra
Active treatment will consist of 2 doses of 1 mg/kg up to 100 mg of anakinra SQ injection.
Placebo
Normal saline injection
Placebo
Injection of NS
Interventions
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Anakinra
Active treatment will consist of 2 doses of 1 mg/kg up to 100 mg of anakinra SQ injection.
Placebo
Injection of NS
Eligibility Criteria
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Inclusion Criteria
* age 18-50 years
Exclusion Criteria
* pregnant women
* smokers
18 Years
50 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Michelle Hernandez, MD
OTHER
Responsible Party
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Michelle Hernandez, MD
Assistant Professor
Principal Investigators
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Michelle Hernandez, MD
Role: PRINCIPAL_INVESTIGATOR
UNC CH SOM
Locations
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UNC Center for Environmental Medicine, Asthma and Lung Biology
Chapel Hill, North Carolina, United States
Countries
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Other Identifiers
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11-1026
Identifier Type: -
Identifier Source: org_study_id
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