NCT00001888已完成不适用
Asthma Sample Collection Protocol
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 574
- 试验地点
- 1
- 主要终点
- Assess the role of apolipoprotein and lipid pathways in asthmatic and non-asthmatic subjects.
研究概览
简要总结
Fiberoptic bronchoscopy is a procedure which involves passing a pencil-thin tube into the lung in order to collect fluid and cells from the airways. Fiberoptic bronchoscopy can collect cells from the walls of airways by gently brushing them (bronchial brushing). In addition, squirting small amounts of sterile water in to the airway and gently suctioning it back into the bronchoscope (bronchoalveolar lavage) collects cells.
In this study, researchers plan to perform these tests on patients with asthma and normal volunteers. This research may help to improve the understanding of the processes involved in airway inflammation and asthma.
详细描述
This tissue procurement protocol proposes to perform bronchoscopy with bronchoalveolar lavage, bronchial brushings, and bronchial wall biopsies, as well as to collect samples of sputum, exhaled breath condensates and blood, in order to evaluate the molecular mechanisms underlying the pathogenesis of airway inflammation, airway hyperresponsiveness, and airway remodeling in asthmatic subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •ASTHMATICS:
- •Patients undergoing a research bronchoscopy will be between 18 and 75 years of age, male or female. The diagnosis of asthma requires a history of intermittent, reversible expiratory flow limitation. In addition, patients will have demonstrated evidence of either an abnormal methacholine challenge or reversible airway obstruction. An abnormal methacholine challenge will be defined as a decrease in FEV1 of at least 20% at a PD20 dose < 200 microgram. Reversible airway obstruction will be defined as an improvement of at least 10% in either the FEV1 or FVC following bronchodilator treatment. Methacholine challenge testing will not be performed if the subject has a history of allergy to methacholine. Results of testing performed by the subject s primary care provider may be accepted as evidence of reversible airflow obstruction.
- •For women of childbearing potential, negative pregnancy test and willingness to adhere to reliable birth control methods prior to
- •bronchoscopy or sputum induction.
- •Asthmatic research subjects who will only be providing research blood specimens, nasal epithelial lining fluid, spontaneously expectorated sputum, or exhaled breath condensate, and will not be undergoing a research bronchoscopy or sputum induction, may participate in the protocol by providing a clinical history that they have asthma and are not pregnant. Documentation of an abnormal methacholine challenge or reversible airflow obstruction or a negative pregnancy test, for women of childbearing age, will not be required for donation of research blood specimens, or other non-invasive samples, such as nasal epithelial lining fluid, sputum, or exhaled breath condensate.
排除标准
- •ASTHMATICS:
- •Diagnosis of a pulmonary disorder other than asthma (e.g., chronic bronchitis, cystic fibrosis, HIV-related lymphocytic airway inflammation).
- •History of drug or alcohol abuse within the past year.
- •Positive test for human immunodeficiency virus (to exclude patients with HIV-related lymphocytic airway inflammation) or hepatitis virus.
- •INCLUSION CRITERIA - RESEARCH VOLUNTEERS:
- •Research volunteers undergoing a research bronchoscopy will be between 18 and 75 years of age, male or female.
- •A negative inhalational methacholine challenge as defined by the absence of a 20% decrease in FEV1 at a PD20 dose of > 400 microgram (normal bronchial hyperresponsiveness). Methacholine challenge testing will not be performed if the subject has a history of allergy to methacholine. Results of testing performed by the subject s primary care provider may be accepted as evidence of a negative methacholine challenge.
- •For women of childbearing potential, negative pregnancy test within 2 weeks prior to bronchoscopy and willingness to adhere to reliable birth control methods prior to bronchoscopy or sputum induction.
- •Research volunteers who will only be providing research blood specimens, nasal epithelial lining fluid, sputum, spontaneously expectorated sputum, or exhaled breath condensate, and will not be undergoing a research bronchoscopy or sputum induction, may be included in the protocol without documentation of a negative inhalational methacholine challenge or a negative pregnancy test if they provide a history that they do not have asthma and that they are not currently pregnant, for women of childbearing age.
- •EXCLUSION CRITERIA - RESEARCH VOLUNTEERS:
- •Same as the asthmatic exclusion criteria plus a history of asthma.
研究组 & 干预措施
2
Research Volunteers
1
Asthmatics
结局指标
主要结局
Assess the role of apolipoprotein and lipid pathways in asthmatic and non-asthmatic subjects.
时间窗: ongoing
These studies will increase the understanding of the pathogenic mechanisms underlying asthmatic airway inflammation and may identify novel therapeutic targets.
次要结局
- Assess the role of exosome-associated proteins and receptors in the regulation of airway inflammatory responses(ongoing)
- Assess the relative contribution of specific soluble pro-inflammatory cytokines and receptors in asthmatic bronchoalveolar lavage fluid (BALF) in mediating airway structural and inflammatory cell responses(ongoing)
- Assess the expression, regulation, and function of proteins regulating the release of soluble receptors and mediators from asthmatic inflammatory and structural cell populations(ongoing)
- Assess the expression, regulation, and function of differentially expressed proteins and genes in human airway structural and inflammatory cell populations in asthma(ongoing)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Segmental Bronchoalveolar LavagePulmonary FibrosisAsthmaNCT00001618National Heart, Lung, and Blood Institute (NHLBI)153
已完成
1 期
A Trial to Determine How Long Insulin and FDKP (the Molecule That Forms Technosphere Particles) Stays in the Lungs of Healthy Individuals After Inhalation of Technosphere® Insulin (TI) Powder Using Bronchoalveolar Lavage (BAL)Healthy SubjectsNCT00757367Mannkind Corporation13
已完成
不适用
"Bronchoscopic Argon Plasma Coagulation for Managing Endobronchial Carcinoid LesionsEndobronchial CarcinoidNCT06757920Alexandria University40
已完成
不适用
Bronchoscopy Assisted Sampling of Cells and Fluid From the Lower Respiratory Tract of Human SubjectsRespiratory DiseasesNCT00840723University of North Carolina, Chapel Hill30
已完成
不适用
Analysis of Bronchial Tissue and Fluid in Patients With Wegener's GranulomatosisInflammationWegener's GranulomatosisVasculitisNCT00001541National Institute of Allergy and Infectious Diseases (NIAID)25