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

July 11, 2013 updated by: Michelle Hernandez, MD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Center for Environmental Medicine, Asthma and Lung Biology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy volunteers
  • age 18-50 years

Exclusion Criteria:

  • asthma
  • pregnant women
  • smokers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 hours after inhalation of CCRE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michelle Hernandez, MD

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Michelle Hernandez, MD, UNC CH SOM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

June 3, 2011

First Submitted That Met QC Criteria

June 7, 2011

First Posted (Estimate)

June 8, 2011

Study Record Updates

Last Update Posted (Estimate)

July 15, 2013

Last Update Submitted That Met QC Criteria

July 11, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-1026
  • 1U19AI077437-03 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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