Ex Vivo Effect of Surfactant Protein D on Pulmonary Immune Cells Derived From Bronchoalveolar Lavage After Segmental Allergen Challenge in Patients With Asthma

August 3, 2010 updated by: Fraunhofer-Institute of Toxicology and Experimental Medicine

The effect of surfactant protein D under native and altered conditions will be investigated in immune cells that are derived from bronchoalveolar lavage in patients with allergic asthma following segmental allergen challenge. The goal of this study is to elucidate the pro- versus anti-inflammatory function of SP-D molecules and to identify motifs of SP-D that have treatment potential in allergic asthma.

Study Overview

Status

Completed

Conditions

Asthma

Intervention / Treatment

Procedure: Bronchoscopy

Detailed Description

Following a baseline BAL, allergen (3×) and saline (1×) will be instilled into four different lung segments during a first bronchoscopy. After 24 hours during a second bronchoscopy BAL will be collected in these challenged segments to harvest invaded cells for in-vitro experimentation. In addition, bronchial biopsies and epithelial brushes will be taken to assess the degree of local inflammation in bronchial mucosa and to study the activation of airway epithelium following allergen challenge.

Study Type

Interventional

Enrollment (Anticipated)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- Niedersachsen
  - Hannover, Niedersachsen, Germany, 30625
    - Fraunhofer ITEM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Able and willing to give written informed consent
Physician diagnosis of mild asthma according to GINA guidelines (7)
age 18-55 years
Nonsmokers with a history of less than 1 packyear having been nonsmokers for at least the last five years
FEV1 ≥ 80% of predicted, FEV1/FVC ≥ 70 %
Positive skin prick test for grass mix or D. pteronyssinus at or within 12 months prior to the screening visit
Positive response to inhaled methacholine (≤ 8 mg/mL)
Positive response to an incremental inhaled allergen challenge with house dust mite allergen or grass pollen allergen
Women will be considered for inclusion if they are:
not pregnant, as confirmed by pregnancy test, and not nursing
of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meet clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit)
of childbearing potential and using a highly effective method of contraception during the entire study (vasectomized partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the study until at least 72 hours after the end of the study -, implants, injectables, combined oral contraceptives, hormonal IUDs, or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap)
Available to complete all study measurements

Exclusion Criteria:

History of upper or lower respiratory tract infection four weeks prior to the informed consent visit
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, psychiatric disease, endocrine disease, infectious disease, inflammatory disease, or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
Clinically significant pathological findings in safety laboratory tests
Regular intake of any medication other than short acting inhaled beta agonists, paracetamol for pain relief, birth control medication, hormonal replacement therapy, dietary and vitamin supplements
Specific Immunotherapy (SIT) within two years prior to the study
Use of anti-inflammatory medication including systemic or inhaled corticosteroid within the last four weeks
Any history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
Suspected hypersensitivity to any ingredients of the medication in line with bronchoscopy (bronchodilators, sedatives and local anesthetics)
Conditions or factors, which would make the subject unlikely to be able to undergo bronchoscopy or incremental allergen challenge
History of drug or alcohol abuse
Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
Participation in a clinical trial 30 days prior to enrolment
Segmental allergen challenge three months prior to treatment
Risk of non-compliance with study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Basic Science
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change of numbers of matured dendritic cells in vitro in the absence and presence of surfactant protein D. Time Frame: 24 h post allergen challenge	24 h post allergen challenge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fraunhofer-Institute of Toxicology and Experimental Medicine

Collaborators

German Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

October 14, 2008

First Submitted That Met QC Criteria