Effect of Interleukin-1 Receptor Antagonist on Inhalation of 20,000 EU Clinical Ctr Reference Endotoxin in Normal Volunteers
- Registration Number
- NCT01369017
- Lead Sponsor
- Michelle Hernandez, MD
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
Inclusion Criteria
- healthy volunteers
- age 18-50 years
Exclusion Criteria
- asthma
- pregnant women
- smokers
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo Normal saline injection Anakinra Anakinra All subjects will undergo 2 CCRE challenges. Each subject will be given either anakinra or placebo prior to CCRE challenge
- Primary Outcome Measures
Name Time Method blockade of IL-1 β will suppress neutrophil response to challenge with 20,000 EU CCRE 6 hours after inhalation of 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UNC Center for Environmental Medicine, Asthma and Lung Biology
🇺🇸Chapel Hill, North Carolina, United States