Status:
TERMINATED
Effect of an Immunotoxin on Activated Human Macrophages in Those With Allergic Rhinitis or Mild Intermittent Asthma
Lead Sponsor:
Fraunhofer-Institute of Toxicology and Experimental Medicine
Conditions:
Atopy
Rhinitis
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The primary objective of this study is to isolate macrophages by using bronchoalveolar lavage (BAL) for different in vitro experiments. Therefore, following a baseline BAL, allergen, endotoxin, and s...
Eligibility Criteria
Inclusion
- Physician diagnosis of atopy (allergic rhinitis or mild intermittent asthma)
- Age 18-55 years
- Nonsmoker (\> 5 years)
- Forced expiratory volume in 1 second (FEV1) \> 70% of the predicted value
- A positive skin prick test for grass mix or D. pteronyssinus at or within 12 months prior to the screening visit
- Informed consent
- Females with negative pregnancy test
Exclusion
- 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 blood tests (differential blood count, blood clotting, electrolytes, liver enzymes, retention parameters)
- Subject is undergoing allergen desensitization therapy
- Permanent medication
- Systemic or inhaled corticosteroid use within the last month
- Anti-inflammatory medication within the last month
- Pregnancy
- Neurological or psychiatric disease or history of drug or alcohol abuse which would interfere with the subject's proper completion of the protocol assignment
- There is a risk of non-compliance with study procedures
- Participation in a clinical trial 30 days prior to enrolment
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00295737
Start Date
February 1 2006
End Date
January 1 2008
Last Update
January 16 2008
Active Locations (1)
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1
Fraunhofer ITEM
Hanover, Germany, 30625