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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00295737
Recruitment Status : Terminated (proof of mechanism achieved with fewer subjects than anticipated)
First Posted : February 24, 2006
Last Update Posted : January 16, 2008
Information provided by:
Fraunhofer-Institute of Toxicology and Experimental Medicine

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.

Condition or disease Intervention/treatment Phase
Atopy Rhinitis Bronchial Asthma Procedure: bronchoscopy, allergen/endotoxin instillation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: 05/04 IMHOTEP-1 FHG: Ex Vivo Effect of an Immunotoxin on Activated Human Macrophages From Atopics After Segmental Instillation of Allergen and Endotoxin
Study Start Date : February 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Primary Outcome Measures :
  1. number of macrophages in bronchoalveolar lavage [ Time Frame: one day after challenge ]

Secondary Outcome Measures :
  1. number of other BAL cells [ Time Frame: one day after challenge ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00295737

Fraunhofer ITEM
Hannover, Germany, 30625
Sponsors and Collaborators
Fraunhofer-Institute of Toxicology and Experimental Medicine
Principal Investigator: Jens Hohlfeld, MD Fraunhofer ITEM Identifier: NCT00295737     History of Changes
Other Study ID Numbers: 05/04 IMHOTEP-1 FHG
First Posted: February 24, 2006    Key Record Dates
Last Update Posted: January 16, 2008
Last Verified: January 2008

Keywords provided by Fraunhofer-Institute of Toxicology and Experimental Medicine:
allergic rhinitis

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Immunologic Factors
Physiological Effects of Drugs