NCT01741805撤回不适用
The Clinical and Laboratory Phenotypes of Severe Asthma Patients in Clalit Health Services Haifa.
Carmel Medical Center1 个研究点 分布在 1 个国家开始时间: 2012年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Forced Expiratory Volume in 1 second (FEV1)
研究概览
简要总结
Asthma is a chronic illness characterized by inflammation of the airways. Severe asthma is defined in the literature as asthma not controlled by medication. In recent years it has become known that severe asthma is a variable disease and has subtypes relating to the age of onset, type of inflammation and allergy, obesity, etc.
Our aim is to characterize the phenotypes of severe asthma population in our clinic and compare the prevalent phenotypes to the phenotypes described before.
详细描述
Study measures will include the following:
- asthma demographic and symptoms questionnaire
- Validation of proper inhaler technique
- Height, weight measurements
- Forced spirometry and reversibility testing
- DLCO
- Fractional excretion of NO in exhaled breath
- Chest and sinus CT
- Induced sputum analysis
- Complete blood count, electrolytes, immunoglobulin E, Aspergillus Specific IgE
- Skin allergy testing
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of Asthma- typical symptoms and signs accompanied by either: a. obstruction in Spirometry, OR- b. positive methacholine test
- •Regular use of high dose of inhaled corticosteroids (1000 micrograms of fluticasone per day or equivalent) in addition to a long acting beta agonist (LABA).
- •Lack of asthma control- 2 or more exacerbations in the past year- exacerbations defined by hospitalization or care in an emergency department or treatment with systemic glucocorticosteroids for exacerbation of asthma symptoms.
排除标准
- •Presence of another relevant respiratory illness, such as chronic obstructive pulmonary disease (COPD)
- •lack of adherence to medical therapy
结局指标
主要结局
Forced Expiratory Volume in 1 second (FEV1)
时间窗: 1 year
次要结局
- Carbon Monoxide Diffusion Capacity (DLCO)(1 year)
- Percent eosinophils in induced sputum sample(1 year)
- Bronchiectasis on computerized tomography (CT)(1 year))
- Blood level of Total immunoglobulin E (IgE)(1 year)
- Presence of blood antibody to Aspergillus Fumigatus(1 year)
- Fraction of Nitric Oxide (NO) in expired air(1 year)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Assessment of Asthma Exacerbation in Children by Modified Pulmonary Index ScoreBronchial AsthmaNCT03190759Assiut University1
招募中
不适用
Identification of Asthma Phenotypes in Severe AsthmaticsAsthmaNCT01623089Singapore General Hospital1,000
已完成
不适用
Clinical Characteristics of Severe Childhood AsthmaSevere AsthmaNCT06024902Children's Hospital of Fudan University650
Unknown
不适用
Epidemiology and Cytokines Analysis of Severe Asthma Patients in TaiwanCytokinesBronchial AsthmaNCT02871947Taipei Veterans General Hospital, Taiwan70
已完成
2 期
Safety, Efficacy, PK, and PD Characteristics of Orally Inhaled SB010 in Male Patients With Mild Asthma (Multiple Dose)AsthmaNCT01743768Sterna Biologicals GmbH & Co. KG38