Trial record 1 of 1 for:
NCT01369017
Effect of Interleukin-1 Receptor Antagonist on Inhalation of 20,000 EU Clinical Ctr Reference Endotoxin in Normal Volunteers (Kintox)
This study is currently recruiting participants.
Verified November 2012 by University of North Carolina, Chapel Hill
Sponsor:
Michelle Hernandez, MD
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: November 13, 2012
Last verified: November 2012
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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.
| Estimated Enrollment: | 21 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 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
Contacts
| Contact: Martha Almond | 919-966-0759 | marrt@med.unc.edu |
Locations
| United States, North Carolina | |
| UNC Center for Environmental Medicine, Asthma and Lung Biology | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Principal Investigator: Michelle Hernandez, MD | |
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: | November 13, 2012 |
| 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 June 17, 2013