Effect of an Immunotoxin on Activated Human Macrophages in Those With Allergic Rhinitis or Mild Intermittent Asthma

Study Overview
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Brief Summary
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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.

Official Title
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05/04 IMHOTEP-1 FHG: Ex Vivo Effect of an Immunotoxin on Activated Human Macrophages From Atopics After Segmental Instillation of Allergen and Endotoxin

Conditions
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Atopy, Rhinitis, Bronchial Asthma

Intervention / Treatment
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* Procedure: bronchoscopy, allergen/endotoxin instillation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: bronchoscopy, allergen/endotoxin instillation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of macrophages in bronchoalveolar lavage |  | one day after challenge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of other BAL cells |  | one day after challenge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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allergic rhinitis