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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01369017
Recruitment Status : Completed
First Posted : June 8, 2011
Last Update Posted : July 15, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Healthy Control Subjects Drug: Anakinra Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Study of the Effect of Interleukin-1 Receptor Antagonist on Inhalation of 20,000 EU Clinical Center Reference Endotoxin in Normal Volunteers
Study Start Date : October 2011
Primary Completion Date : July 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Anakinra
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Anakinra
All subjects will undergo 2 CCRE challenges. Each subject will be given either anakinra or placebo prior to CCRE challenge
Drug: Anakinra
Active treatment will consist of 2 doses of 1 mg/kg up to 100 mg of anakinra SQ injection.
Placebo Comparator: Placebo
Normal saline injection
Drug: Placebo
Injection of NS

Outcome Measures

Primary Outcome Measures :
  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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy volunteers
  • age 18-50 years

Exclusion Criteria:

  • asthma
  • pregnant women
  • smokers
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01369017

United States, North Carolina
UNC Center for Environmental Medicine, Asthma and Lung Biology
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
Michelle Hernandez, MD
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Michelle Hernandez, MD UNC CH SOM
More Information

Responsible Party: Michelle Hernandez, MD, Assistant Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01369017     History of Changes
Other Study ID Numbers: 11-1026
1U19AI077437-03 ( U.S. NIH Grant/Contract )
First Posted: June 8, 2011    Key Record Dates
Last Update Posted: July 15, 2013
Last Verified: July 2013

Keywords provided by Michelle Hernandez, MD, University of North Carolina, Chapel Hill:
healthy volunteer

Additional relevant MeSH terms:
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents