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
  Purpose

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 Intervention
Atopy
Rhinitis
Bronchial Asthma
Procedure: bronchoscopy, allergen/endotoxin instillation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Fraunhofer-Institute of Toxicology and Experimental Medicine:

Primary Outcome Measures:
  • number of macrophages in bronchoalveolar lavage [ Time Frame: one day after challenge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of other BAL cells [ Time Frame: one day after challenge ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: February 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295737

Locations
Germany
Fraunhofer ITEM
Hannover, Germany, 30625
Sponsors and Collaborators
Fraunhofer-Institute of Toxicology and Experimental Medicine
Investigators
Principal Investigator: Jens Hohlfeld, MD Fraunhofer ITEM
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00295737     History of Changes
Other Study ID Numbers: 05/04 IMHOTEP-1 FHG
Study First Received: February 22, 2006
Last Updated: January 15, 2008
Health Authority: Germany: Federal Agency for Sera and Vaccines

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

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

ClinicalTrials.gov processed this record on August 20, 2014