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:
Fraunhofer-Institute of Toxicology and Experimental Medicine
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 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 June 17, 2013