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
  Purpose

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 Intervention Phase
Healthy Control Subjects
Drug: Anakinra
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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.


Enrollment: 17
Study Start Date: October 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers
  • age 18-50 years

Exclusion Criteria:

  • asthma
  • pregnant women
  • smokers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01369017

Locations
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
Investigators
Principal Investigator: Michelle Hernandez, MD UNC CH SOM
  More Information

No publications provided

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, 1U19 AI077437-03
Study First Received: June 3, 2011
Last Updated: July 11, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
healthy volunteer
endotoxin

Additional relevant MeSH terms:
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014