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TerminatedNCT00295737Updated Jan 16, 2008

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

An interventional study of bronchoscopy, allergen/endotoxin instillation in Atopy, Rhinitis and Bronchial Asthma, sponsored by Fraunhofer-Institute of Toxicology and Experimental Medicine. Terminated at 1 site in Germany. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2008-01-16.

Sponsored by Fraunhofer-Institute of Toxicology and Experimental Medicine · Not applicable and Interventional

Why this study was terminated
proof of mechanism achieved with fewer subjects than anticipated
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Atopy
  • Rhinitis
  • Bronchial Asthma

Keywords

  • allergic rhinitis
03

In context

Rhinitis

1,101 studies on the registry are indexed under Rhinitis; 63 are open to participants now.

This study's enrollment of 8 is below the median of 89 across 903 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Fraunhofer-Institute of Toxicology and Experimental Medicine is the lead sponsor of 37 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Interventions

  • Procedurebronchoscopy, allergen/endotoxin instillation
06

What researchers measure

Primary outcomes

  1. number of macrophages in bronchoalveolar lavage

    Time frame: one day after challenge

Secondary outcomes

  1. number of other BAL cells

    Time frame: one day after challenge

07

Study locations

1 site
  • Fraunhofer ITEM
    Hanover, 30625, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00295737
Lead sponsor
Fraunhofer-Institute of Toxicology and Experimental Medicine
First posted
Feb 24, 2006
Start date
Feb 2006
Primary completion
Jan 2008
Completion
Jan 2008
Last update
Jan 16, 2008

Study contacts

Jens Hohlfeld, MD
principal investigator · Fraunhofer ITEM
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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