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
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|ClinicalTrials.gov Identifier: NCT01378624|
Recruitment Status : Completed
First Posted : June 22, 2011
Last Update Posted : October 31, 2013
|Condition or disease||Intervention/treatment||Phase|
|Mild Intermittent Asthma (Gina 1)||Other: Bronchoscopy||Not Applicable|
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 and to assess local inflammation induced by segmental allergen challenge by magnetic resonance imaging.
In addition to the patients with allergic asthma a subgroup of five healthy subjects will be included into the study to elucidate the specificity of the SP-D (surfactant protein-D) effect on the allergic inflammation in the invitro models.
The primary objective of this study is to isolate BAL cells for different invitro experiments and to assess local inflammation after segmental allergen challenge by MRI in response to the applied allergen dose.
Therefore, following a baseline BAL, allergen (2× individual dose, 1× one tenth of individual dose) 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 invitro 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 (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||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|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
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.
- Change in local inflammation [ Time Frame: Baseline, 6 and 24 hours post segmental allergen challenge ]Magnetic resonance imaging to assess local inflammation prior to as well as 6 h and 24 h after segmental allergen challenge
- Change of numbers of matured dendritic cells [ Time Frame: Baseline and 24 h post segmental allergen challenge ]Change of numbers of matured dendritic cells in vitro in the absence and presence of surfactant protein D.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01378624
|Hannover, Niedersachsen, Germany, 30625|
|Principal Investigator:||Jens Hohlfeld, MD, Professor||Fraunhofer ITEM|