NCT01369017

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 8, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 15, 2013

Status Verified

July 1, 2013

Enrollment Period

1.8 years

First QC Date

June 3, 2011

Last Update Submit

July 11, 2013

Conditions

Healthy Control Subjects

Keywords

healthy volunteerendotoxin

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 hours after inhalation of CCRE

Study Arms (2)

Anakinra

ACTIVE COMPARATOR

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

Drug: Anakinra

Placebo

PLACEBO COMPARATOR

Normal saline injection

Drug: Placebo

Interventions

AnakinraDRUG

Active treatment will consist of 2 doses of 1 mg/kg up to 100 mg of anakinra SQ injection.

Anakinra
PlaceboDRUG

Injection of NS

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteers
  • age 18-50 years

You may not qualify if:

  • asthma
  • pregnant women
  • smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Center for Environmental Medicine, Asthma and Lung Biology

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Interventions

Interleukin 1 Receptor Antagonist Protein

Intervention Hierarchy (Ancestors)

CytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Michelle Hernandez, MD

    UNC CH SOM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 3, 2011

First Posted

June 8, 2011

Study Start

October 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 15, 2013

Record last verified: 2013-07

Locations

US(1)