A Study to Assess Disease Pathology and Key Therapeutic Targets in Severe Asthma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Airway pathology endpoints Target Validation endpoints Biomarker endpoints Clinical endpoints
研究概览
简要总结
To evaluate and compare the expression and change in expression of key severe asthma targets at baseline in mile to moderate asthmatics vs. severe asthmatic subjects.
To evaluate and compare the airway pathology at baseline and changes in airway pathology in relation to asthma severity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intermittent mild steroid-naïve asthmatic group
Asymptomatic subjects receiving only beta-agonist inhaler with predicted FEV1 >=80% and normal peak expiratory flow between attacks will be included.
干预措施: Prednisolone (Drug)
Intermittent mild steroid-naïve asthmatic group
Asymptomatic subjects receiving only beta-agonist inhaler with predicted FEV1 >=80% and normal peak expiratory flow between attacks will be included.
干预措施: Bronchoscopy (Procedure)
Mild to moderate persistent asthmatic group
Subjects with mild to moderate persistent asthma on low to moderate dose of inhaled corticosteroid (200-500 microgram fluticasone propionate daily or equivalent), an FEV1 >= 80% predicted (post-bronchodilator), and less than 20% variability in peak expiratory flow.
干预措施: Prednisolone (Drug)
Mild to moderate persistent asthmatic group
Subjects with mild to moderate persistent asthma on low to moderate dose of inhaled corticosteroid (200-500 microgram fluticasone propionate daily or equivalent), an FEV1 >= 80% predicted (post-bronchodilator), and less than 20% variability in peak expiratory flow.
干预措施: Bronchoscopy (Procedure)
Severe asthma group
Subjects with severe persistent asthma. They will be on either: high inhaled corticosteroid (CS >=1000 microgram fluticasone daily or equivalent) or on high dose inhaled CS plus oral CS (no more than 20 milligrams predisolone a day). The subjects should have at least one ( if on oral steroids) or two (if only on inhaled steroids) of the following: 1) FEV1<80% and FEV1/FVC ratio <70% 2) more than 25% variability in peak expiratory flow 3) daily symptoms ± nocturnal symptoms 4) severe exacerbations of >= twice a year in at least one of the last two years.
干预措施: Prednisolone (Drug)
Severe asthma group
Subjects with severe persistent asthma. They will be on either: high inhaled corticosteroid (CS >=1000 microgram fluticasone daily or equivalent) or on high dose inhaled CS plus oral CS (no more than 20 milligrams predisolone a day). The subjects should have at least one ( if on oral steroids) or two (if only on inhaled steroids) of the following: 1) FEV1<80% and FEV1/FVC ratio <70% 2) more than 25% variability in peak expiratory flow 3) daily symptoms ± nocturnal symptoms 4) severe exacerbations of >= twice a year in at least one of the last two years.
干预措施: Bronchoscopy (Procedure)
Healthy subjects group
Non-asthmatic and non-smokers with FEV1 > 85% predicted, on no regular medication.
干预措施: Bronchoscopy (Procedure)
结局指标
主要结局
Airway pathology endpoints Target Validation endpoints Biomarker endpoints Clinical endpoints
时间窗: Through 2 weeks of Prednisolone dosing
biomarkers, vital signs, ECG
次要结局
- Expression of airway and systemic biomarkers. Relationship between changes in target expression and clinical measures of disease activity. Relationship between steady state plasma exposure of prednisolone and pharmacodynamic biomarkers.(Through 2 weeks of prednisolone dosing.)