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OpenTrials
Completed

NCT Number: NCT01369017

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

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.

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Key information

Conditions

Healthy Control Subjects

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UNC Center for Environmental Medicine, Asthma and Lung Biology

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy volunteers
  • age 18-50 years

Exclusion criteria

  • asthma
  • pregnant women
  • smokers

Treatment and study plan

Anakinra

Drug

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

Placebo

Drug

Injection of NS

Primary outcomes

  1. blockade of IL-1 β will suppress neutrophil response to challenge with 20,000 EU CCRE

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Michelle Hernandez, MD

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

A Study of the Effect of Interleukin-1 Receptor Antagonist on Inhalation of 20,000 EU Clinical Center Reference Endotoxin in Normal Volunteers

Acronym: Kintox

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 8, 2011
Registry last updated
Jul 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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