Ex Vivo Effect of Surfactant Protein D on Pulmonary Cells in Patients With Asthma and Pilot Study to Assess Local Inflammation Induced by Segmental Allergen Challenge by Magnetic Resonance Imaging

NCT01378624 | Completed

• 1 other identifier: 10-07 ZAP2
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Ex vivo effect of fragments and modified forms of surfactant protein D on pulmonary immune cells derived from bronchoalveolar lavage after segmental allergen challenge in patients with asthma and pilot study to assess local inflammation induced by segmental allergen challenge by magnetic resonance imaging.

Conditions

Mild Intermittent Asthma (Gina 1)

Outcome Measures

Primary Outcomes (2)

• Change in local inflammation

  Magnetic resonance imaging to assess local inflammation prior to as well as 6 h and 24 h after segmental allergen challenge

  Baseline, 6 and 24 hours post segmental allergen challenge

• Change of numbers of matured dendritic cells

  Change of numbers of matured dendritic cells in vitro in the absence and presence of surfactant protein D.

  Baseline and 24 h post segmental allergen challenge

Study Arms (1)

Bronchoscopy

EXPERIMENTAL

Other: Bronchoscopy

Interventions

Bronchoscopy OTHER

In brief, during the first bronchoscopy a baseline BAL and baseline endobronchial brush and forceps biopsies will be obtained and allergen as well as saline (control segment) will be instilled. The subjects will undergo a second bronchoscopy in order to obtain BAL from the allergen challenged segments and the saline challenged segment, and endobronchial forceps biopsies.

Bronchoscopy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able and willing to give written informed consent
• Physician diagnosis of mild asthma according to GINA guidelines (1;7)
• Nonsmokers with a history of less than 1 pack a year having been nonsmokers for at least the last five years
• FEV1 80% of predicted
• Positive skin prick test for grass mix or D. pteronyssinus at or within 12 months prior to the screening visit
• Positive response to an incremental inhaled allergen challenge with house dust mite allergen or grass pollen allergen
• 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)o 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)

You may not qualify if:

• 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
• Conditions or factors, which would make the subject unable to undergo MRI such as metal containing implants, remainders of shell splinters or bullets, or claustrophobia.
• 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 enrollment
• Segmental allergen challenge three months prior to treatment
• Risk of non-compliance with study procedures

Sponsors & Collaborators

• Fraunhofer-Institute of Toxicology and Experimental Medicine: lead
• Hannover Medical School: collaborator

Study Sites (1)

Fraunhofer ITEM

Hanover, Lower Saxony, 30625, Germany

Location

MeSH Terms

Interventions

Bronchoscopy

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

Study Officials

• Jens Hohlfeld, MD, Professor

  Fraunhofer ITEM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 17, 2011
• First Posted: June 22, 2011
• Study Start: June 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 31, 2013

Record last verified: 2013-10

Locations

DE (1)