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

Primary Purpose

Healthy Control Subjects

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Anakinra
Placebo
Sponsored by
Michelle Hernandez, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy Control Subjects focused on measuring healthy volunteer, endotoxin

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy volunteers
  • age 18-50 years

Exclusion Criteria:

  • asthma
  • pregnant women
  • smokers

Sites / Locations

  • UNC Center for Environmental Medicine, Asthma and Lung Biology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Anakinra

Placebo

Arm Description

All subjects will undergo 2 CCRE challenges. Each subject will be given either anakinra or placebo prior to CCRE challenge

Normal saline injection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 3, 2011
Last Updated
July 11, 2013
Sponsor
Michelle Hernandez, MD
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT01369017
Brief Title
Effect of Interleukin-1 Receptor Antagonist on Inhalation of 20,000 EU Clinical Ctr Reference Endotoxin in Normal Volunteers
Acronym
Kintox
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 Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michelle Hernandez, MD
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Control Subjects
Keywords
healthy volunteer, endotoxin

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anakinra
Arm Type
Active Comparator
Arm Description
All subjects will undergo 2 CCRE challenges. Each subject will be given either anakinra or placebo prior to CCRE challenge
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline injection
Intervention Type
Drug
Intervention Name(s)
Anakinra
Intervention Description
Active treatment will consist of 2 doses of 1 mg/kg up to 100 mg of anakinra SQ injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Injection of NS
Primary Outcome Measure Information:
Title
blockade of IL-1 β will suppress neutrophil response to challenge with 20,000 EU CCRE
Description
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.
Time Frame
6 hours after inhalation of CCRE

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy volunteers age 18-50 years Exclusion Criteria: asthma pregnant women smokers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Hernandez, MD
Organizational Affiliation
UNC CH SOM
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Center for Environmental Medicine, Asthma and Lung Biology
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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