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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00295737

Enrollment

Registered

2006-02-24

Start date

2006-02-28

Completion date

2008-01-31

Last updated

2008-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopy, Bronchial Asthma, Rhinitis

Keywords

allergic rhinitis

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 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.

Interventions

PROCEDUREbronchoscopy, allergen/endotoxin instillation

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
number of macrophages in bronchoalveolar lavage	one day after challenge

Secondary

Measure	Time frame
number of other BAL cells	one day after challenge

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026