Trial record 1 of 1 for:    NCT01369017
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Effect of Interleukin-1 Receptor Antagonist on Inhalation of 20,000 EU Clinical Ctr Reference Endotoxin in Normal Volunteers (Kintox)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michelle Hernandez, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01369017
First received: June 3, 2011
Last updated: July 11, 2013
Last verified: July 2013

June 3, 2011
July 11, 2013
October 2011
July 2013   (final data collection date for primary outcome measure)
blockade of IL-1 β will suppress neutrophil response to challenge with 20,000 EU CCRE [ Time Frame: 6 hours after inhalation of CCRE ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01369017 on ClinicalTrials.gov Archive Site
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Effect of Interleukin-1 Receptor Antagonist on Inhalation of 20,000 EU Clinical Ctr Reference Endotoxin in Normal Volunteers
A Study of the Effect of Interleukin-1 Receptor Antagonist on Inhalation of 20,000 EU Clinical Center 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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Healthy Control Subjects
  • Drug: Anakinra
    Active treatment will consist of 2 doses of 1 mg/kg up to 100 mg of anakinra SQ injection.
  • Drug: Placebo
    Injection of NS
  • Active Comparator: Anakinra
    All subjects will undergo 2 CCRE challenges. Each subject will be given either anakinra or placebo prior to CCRE challenge
    Intervention: Drug: Anakinra
  • Placebo Comparator: Placebo
    Normal saline injection
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
July 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy volunteers
  • age 18-50 years

Exclusion Criteria:

  • asthma
  • pregnant women
  • smokers
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01369017
11-1026, 1U19 AI077437-03
Yes
Michelle Hernandez, MD, University of North Carolina, Chapel Hill
Michelle Hernandez, MD
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Michelle Hernandez, MD UNC CH SOM
University of North Carolina, Chapel Hill
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP