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

Healthy Control Subjects Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01369017
• Other study ID #: 11-1026
• Secondary ID: 1U19 AI077437-03
• Status: Completed
• Phase: Phase 1
• First received: June 3, 2011
• Last updated: July 11, 2013
• Start date: October 2011
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• healthy volunteers

• age 18-50 years

Exclusion Criteria:

• asthma

• pregnant women

• smokers

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Control Subjects

Intervention

Drug:
• Anakinra
Active treatment will consist of 2 doses of 1 mg/kg up to 100 mg of anakinra SQ injection.
• Placebo
Injection of NS

Locations

Country	Name	City	State
United States	UNC Center for Environmental Medicine, Asthma and Lung Biology	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Michelle Hernandez, MD	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blockade of IL-1 ß 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	Yes