Study to Explore the Effects of Two Hour Inhalation of Ultrafine Carbon Black Particles on Airway Inflammation in Asthmatics

NCT00527462 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2008-04-30

No results posted yet for this study

Summary

The aim of the study is to test the hypothesis that the allergic airway inflammation in asthmatic patients will be enhanced after exposure to ultrafine particles (UFP). In order to test this in a controlled study, the researchers combine controlled exposure to carbon black model UFP with the well-established model of a segmental allergen challenge, which allows the researchers to safely induce circumscript allergic inflammation in the lung in mild asthmatics. The effect of the UFP on allergic inflammation will be controlled by an inhalation of clean air in a randomized, double-blind, crossover design.

Conditions

Interventions

PROCEDURE

Bronchoscopy

bronchoscopy with segmental allergen challenge

OTHER

Exposure to ultrafine carbon black particles

Exposure to ultrafine carbon black particles for 2 hours

Sponsors & Collaborators

  • German Research Foundation

    collaborator OTHER
  • Fraunhofer-Institute of Toxicology and Experimental Medicine

    lead OTHER

Principal Investigators

  • Norbert Krug, Professor, MD · Fraunhofer-Institut, Toxikologie und Experimentelle Medizin

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00527462 on ClinicalTrials.gov