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

This study has been terminated.
(proof of mechanism achieved with fewer subjects than anticipated)
Sponsor:
Information provided by:
Fraunhofer-Institute of Toxicology and Experimental Medicine
ClinicalTrials.gov Identifier:
NCT00295737
First received: February 22, 2006
Last updated: January 15, 2008
Last verified: January 2008

February 22, 2006
January 15, 2008
February 2006
January 2008   (final data collection date for primary outcome measure)
number of macrophages in bronchoalveolar lavage [ Time Frame: one day after challenge ] [ Designated as safety issue: No ]
number of macrophages in bronchoalveolar lavage
Complete list of historical versions of study NCT00295737 on ClinicalTrials.gov Archive Site
number of other BAL cells [ Time Frame: one day after challenge ] [ Designated as safety issue: No ]
number of other BAL cells
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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.

Not Provided
Interventional
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Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Atopy
  • Rhinitis
  • Bronchial Asthma
Procedure: bronchoscopy, allergen/endotoxin instillation
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00295737
05/04 IMHOTEP-1 FHG
Not Provided
Not Provided
Fraunhofer-Institute of Toxicology and Experimental Medicine
Not Provided
Principal Investigator: Jens Hohlfeld, MD Fraunhofer ITEM
Fraunhofer-Institute of Toxicology and Experimental Medicine
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP