- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00295737
Effect of an Immunotoxin on Activated Human Macrophages in Those With Allergic Rhinitis or Mild Intermittent Asthma
05/04 IMHOTEP-1 FHG: Ex Vivo Effect of an Immunotoxin on Activated Human Macrophages From Atopics After Segmental Instillation of Allergen and Endotoxin
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 saline will be instilled into three different lung segments during the first bronchoscopy. After 24 hours during a second bronchoscopy, BAL fluid will be collected in these challenged segments to harvest invaded cells for in vitro experimentation. In addition, segmental bronchial biopsies will be taken to assess the degree of local inflammation.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hannover, Germany, 30625
- Fraunhofer ITEM
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 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 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
Study Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of macrophages in bronchoalveolar lavage
Time Frame: one day after challenge
|
one day after challenge
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of other BAL cells
Time Frame: one day after challenge
|
one day after challenge
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05/04 IMHOTEP-1 FHG
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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