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

This study has been completed.
Sponsor:
Collaborator:
German Research Foundation
Information provided by:
Fraunhofer-Institute of Toxicology and Experimental Medicine
ClinicalTrials.gov Identifier:
NCT00771992
First received: October 14, 2008
Last updated: August 3, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention
Asthma
Procedure: Bronchoscopy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Ex Vivo Effect of Surfactant Protein D on Pulmonary Immune Cells Derived From Bronchoalveolar Lavage After Segmental Allergen Challenge in Patients With Asthma

Resource links provided by NLM:


Further study details as provided by Fraunhofer-Institute of Toxicology and Experimental Medicine:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: October 2008
Study Completion Date: June 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Bronchoscopy
    Bronchoscopy with segmental allergen challenge
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771992

Locations
Germany
Fraunhofer ITEM
Hannover, Niedersachsen, Germany, 30625
Sponsors and Collaborators
Fraunhofer-Institute of Toxicology and Experimental Medicine
German Research Foundation
Investigators
Principal Investigator: Jens Hohlfeld, MD Fraunhofer ITEM
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Dr. Jens Hohlfeld, Fraunhofer ITEM
ClinicalTrials.gov Identifier: NCT00771992     History of Changes
Other Study ID Numbers: 08/09 ZAP-SFB
Study First Received: October 14, 2008
Last Updated: August 3, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Fraunhofer-Institute of Toxicology and Experimental Medicine:
Asthma GINA 1

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pulmonary Surfactants
Pulmonary Surfactant-Associated Protein D
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014