NCT00771992已完成不适用
Ex Vivo Effect of Surfactant Protein D on Pulmonary Immune Cells Derived From Bronchoalveolar Lavage After Segmental Allergen Challenge in Patients With Asthma
Fraunhofer-Institute of Toxicology and Experimental Medicine2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2008年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- change of numbers of matured dendritic cells in vitro in the absence and presence of surfactant protein D.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
change of numbers of matured dendritic cells in vitro in the absence and presence of surfactant protein D.
时间窗: 24 h post allergen challenge
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
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 ImagingMild Intermittent Asthma (Gina 1)NCT01378624Fraunhofer-Institute of Toxicology and Experimental Medicine15
招募中
不适用
Elucidating the Role of Surfactant Protein D (SP-D) in Prostate CancerCTRI/2016/04/006890IRRH15
已完成
不适用
Accuracy of Lung Injury Biomarkers in the Initial Investigation of Patients With Suspected PneumoniaCommunity-acquired PneumoniaNCT04686331University of Southern Denmark411
Unknown
不适用
Lung PGD Biomarkers in Organ DonorsLung Transplant FailureNCT03089489University Hospital of Mont-Godinne50
已完成
不适用
Surfactant Protein D Levels in Covid-19 Infection: Case-Control StudyCovid19Surfactant Protein DeficiencyPneumoniaNCT04618861Kafkas University127