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

NCT00295737 | Terminated

• 1 other identifier: 05/04 IMHOTEP-1 FHG
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopy; Rhinitis; Bronchial Asthma

Keywords

allergic rhinitis

Outcome Measures

Primary Outcomes (1)

• number of macrophages in bronchoalveolar lavage

  one day after challenge

Secondary Outcomes (1)

• number of other BAL cells

  one day after challenge

Interventions

bronchoscopy, allergen/endotoxin instillation PROCEDURE

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fraunhofer-Institute of Toxicology and Experimental Medicine: lead

Study Sites (1)

Fraunhofer ITEM

Hanover, 30625, Germany

Location

MeSH Terms

Conditions

Rhinitis; Asthma; Rhinitis, Allergic

Interventions

Bronchoscopy; Allergens

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Antigens; Biological Factors

Study Officials

• Jens Hohlfeld, MD

  Fraunhofer ITEM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 22, 2006
• First Posted: February 24, 2006
• Study Start: February 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: January 16, 2008

Record last verified: 2008-01

Locations

DE (1)