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

Michelle Hernandez, MD

Status and phase: Completed; Phase 1

Conditions: Healthy Control Subjects

Treatments: Drug: Placebo; Drug: Anakinra

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01369017

1U19AI077437-03 (U.S. NIH Grant/Contract)

11-1026

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy volunteers
• age 18-50 years

Exclusion criteria

• asthma
• pregnant women
• smokers

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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17 participants in 2 patient groups, including a placebo group

Anakinra

Active Comparator group

Description:

All subjects will undergo 2 CCRE challenges. Each subject will be given either anakinra or placebo prior to CCRE challenge

Treatment:

Drug: Anakinra

Placebo

Placebo Comparator group

Description:

Normal saline injection

Treatment:

Drug: Placebo