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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 22, 2006

Last Updated Date

January 15, 2008

Start Date ^ICMJE

February 2006

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

number of macrophages in bronchoalveolar lavage

Change History

Complete list of historical versions of study NCT00295737 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

number of other BAL cells

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Atopy
Rhinitis
Bronchial Asthma

Intervention ^ICMJE

Procedure: bronchoscopy, allergen/endotoxin instillation

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

January 2008

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00295737

Other Study ID Numbers ^ICMJE

05/04 IMHOTEP-1 FHG

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Fraunhofer-Institute of Toxicology and Experimental Medicine

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jens Hohlfeld, MD

Fraunhofer ITEM

Information Provided By

Fraunhofer-Institute of Toxicology and Experimental Medicine

Verification Date

January 2008

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

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