- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00527462
Study to Explore the Effects of Two Hour Inhalation of Ultrafine Carbon Black Particles on Airway Inflammation in Asthmatics
April 28, 2008 updated by: Fraunhofer-Institute of Toxicology and Experimental Medicine
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Niedersachsen
-
Hannover, Niedersachsen, Germany, 30623
- Fraunhofer-Institut für Toxikologie und Experimentelle Medizin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
difference of the number of total cells in bronchoalveolar lavage resulting in the comparison of allergenic versus control segments
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Norbert Krug, Professor, MD, Fraunhofer-Institut, Toxikologie und Experimentelle Medizin
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
April 1, 2008
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
September 10, 2007
First Submitted That Met QC Criteria
September 10, 2007
First Posted (Estimate)
September 11, 2007
Study Record Updates
Last Update Posted (Estimate)
April 30, 2008
Last Update Submitted That Met QC Criteria
April 28, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07/06 UFP-SFB DFG
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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