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

This study has been completed.
Sponsor:
Collaborator:
German Research Foundation
Information provided by:
Fraunhofer-Institute of Toxicology and Experimental Medicine
ClinicalTrials.gov Identifier:
NCT00527462
First received: September 10, 2007
Last updated: April 28, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention
Asthma
Procedure: Bronchoscopy
Other: Exposure to ultrafine carbon black particles

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: Mono-Center, Double-Blind, Cross-Over Study to Explore the Effects of Two Hour Inhalation of Ultrafine Carbon Black Particles Versus Filtered Air on Airway Inflammation Induced by Segmental Allergen Challenge in Asthmatics

Resource links provided by NLM:


Further study details as provided by Fraunhofer-Institute of Toxicology and Experimental Medicine:

Primary Outcome Measures:
  • difference of the number of total cells in bronchoalveolar lavage resulting in the comparison of allergenic versus control segments [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: September 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Bronchoscopy
    bronchoscopy with segmental allergen challenge
    Other: Exposure to ultrafine carbon black particles
    Exposure to ultrafine carbon black particles for 2 hours
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects, aged 18-45 years.
  • Women will be considered for inclusion if they are:

    • Not pregnant, as confirmed by a pregnancy test and not nursing.
    • Not of child-bearing capacity (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meets clinical criteria for menopause and has been amenorrheal for more than 1 year prior to the screening visit).
    • Of child-bearing capacity and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence [the lifestyle of the female should be such that there is complete abstinence from intercourse two weeks prior to the first dose of study medication until at least 72 hours after treatment], implants, injectables, combined oral contraceptives, hormonal intrauterine devices [IUDs]).
  • Physician diagnosis of mild intermittent seasonal asthma
  • Non-smokers, or ex-smokers
  • Forced expiratory volume in 1 second (FEV1) > 80% of the predicted value
  • Positive skin prick test for grass mix at or within 12 months prior to the screening visit
  • Able and willing to give written informed consent to take part in the study
  • Available to complete all study measurements
  • Able to restrain from particle rich atmosphere (e.g. passive cigarette smoke) within 1 week before exposure to UFP or clean air

Exclusion Criteria:

  • Infections of the respiratory tract within the last month
  • Past or present disease which, as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
  • Pathological findings in safety laboratory tests
  • Subjects with clinically relevant infection or known ongoing clinically relevant inflammatory process
  • Suspected hypersensitivity to any ingredients of the medication involved with bronchoscopy (bronchodilators, sedatives and local anaesthetics)
  • Specific immunotherapy (SIT) within two years prior to the study
  • Administration of oral, injectable, or dermal corticosteroids according to 9.2
  • Neurological or psychiatric disease or history of drug or alcohol abuse which would interfere with the subject's proper completion of the protocol assignment
  • Risk of non-compliance with study procedures
  • Participation in another clinical trial 30 days prior to enrolment
  • Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
  • Unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., language problems, uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527462

Locations
Germany
Fraunhofer-Institut für Toxikologie und Experimentelle Medizin
Hannover, Niedersachsen, Germany, 30623
Sponsors and Collaborators
Fraunhofer-Institute of Toxicology and Experimental Medicine
German Research Foundation
Investigators
Principal Investigator: Norbert Krug, Professor, MD Fraunhofer-Institut, Toxikologie und Experimentelle Medizin
  More Information

No publications provided

Responsible Party: Prof. Dr. Norbert Krug, Fraunhofer ITEM
ClinicalTrials.gov Identifier: NCT00527462     History of Changes
Other Study ID Numbers: 07/06 UFP-SFB DFG
Study First Received: September 10, 2007
Last Updated: April 28, 2008
Health Authority: Germany: Ethics Commission

Keywords provided by Fraunhofer-Institute of Toxicology and Experimental Medicine:
Asthma GINA 1

Additional relevant MeSH terms:
Asthma
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014