ACTRN12614001109695招募中未知
A study to investigate the underlying molecular characteristics of allergic asthma by comparing biomarkers in the airways or blood among healthy subjects, mild and severe asthmatics.
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
入排标准
- 年龄范围
- 6 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Participants:
- •This is a prospective case control study; we will recruit the following subjects:
- •1.Stable allergic asthma. Subjects aged 6 – 75 years with mild-to-moderate asthma (control of asthma symptoms (Asthma control questionnaire (ACQ6) score <1.5), and who have evidence of AHR to hypertonic saline and allergic sensitization to common inhalant allergens. On less than 1000mcg/d beclomethasone equivalent.
- •2.Severe uncontrolled allergic asthma, suitable for Omalizumab. Participants with severe refractory asthma, 18 years and older who have persistent poor asthma control (ACQ6 >1.5) despite treatment with greater than 1000mcg/d beclomethasone equivalent per day and a history of an acute exacerbation in the last 12 months requiring systemic corticosteroids for 3 days or more, and who are suitable for commencement of treatment with omalizumab.
- •3.Healthy controls. Non-asthmatic subjects aged 6 – 75 years with normal lung function and no allergic sensitization.
- •Key inclusion criteria
- •Cases with severe allergic asthma
- •*Asthma diagnosis, and who have evidence of AHR to hypertonic saline or change in FEV1 following bronchodilator >12% and at least 200mls.
- •*Age: 18 years and older and determined to be suitable for omalizumab treatment
- •*Regular maintenance treatment with inhaled corticosteroid and long acting beta agonist (dose of ICS >1000mcg/d fluticasone or 1600mcg/d of budesonide)
- •*Evidence of atopy, defined by positive skin prick test or RAST.
- •*Total serum IgE >75 IU/ml
- •*Persistent poor symptom control (ACQ6 >1.5).
- •*Oral corticosteroid use of at least 10mg/d of prednisone for at least 6 weeks in the last 12 months.
- •*Current non-smoker with <10 pack year history of smoking
- •Cases with controlled mild to moderate allergic asthma
- •*Asthma diagnosis, and who have evidence of AHR to hypertonic saline or change in FEV1 following bronchodilator >12% and at least 200mls.
- •*Age 6 -75 years
- •*Regular maintenance treatment with inhaled corticosteroid (dose of ICS <1000mcg/d fluticasone or 1600mcg/d of budesonide)
- •*Evidence of atopy, defined by positive skin prick test or RAST.
- •*Good asthma symptom control (ACQ6 <1.5)
- •*Current non-smoker with <10 pack year history of smoking
- •Healthy controls
- •*Normal lung function; FEV1 >80% predicted, FER >70% predicted and no evidence of AHR to hypertonic saline or change in FEV1 following bronchodilator >12% and at least 200mls.
- •*Age 6 -75 years
- •*No previous history of chronic cardiac or respiratory disease
- •*Non-atopic, negative skin prick test or RAST
- •*Current non-smoker with <10 pack year history of smoking
排除标准
- •*Acute exacerbation of asthma within the last 4 weeks that required a change in treatment
- •*History of a viral respiratory tract infection within the last 4 weeks.
- •*Current smoker or former smoker with >10 pack year history of smoking.
- •*Inability to understand or comply with the study requirements
研究者
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