Effect of Interleukin-1 Receptor Antagonist on Inhalation of 20,000 EU Clinical Ctr Reference Endotoxin in Normal Volunteers

Michelle Hernandez, MD17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy Control Subjects

Interventions

AnakinraDRUG

Active treatment will consist of 2 doses of 1 mg/kg up to 100 mg of anakinra SQ injection.

PlaceboDRUG

Injection of NS

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * healthy volunteers * age 18-50 years Exclusion Criteria: * asthma * pregnant women * smokers

Locations (1)

UNC Center for Environmental Medicine, Asthma and Lung Biology

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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