NCT02464995Unknown不适用
Bronchial Thermoplasty in Severe Asthma With Frequent Exacerbations
University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2015年6月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Severe exacerbation rate (change from baseline)
研究概览
简要总结
The purpose of this study is to demonstrate the effectiveness of bronchial thermoplasty in a severe asthmatic population with frequent exacerbations.
This will be a single center randomized and controlled study. Thirty subjects with severe asthma (Gina 4 and 5) with frequent severe exacerbations (four or more bursts of systemic corticosteroids >3 days each in the previous year) will be randomized 1:1 to either the thermoplasty group (bronchial thermoplasty and medical management) or control group (medical management only).
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
- •Age 18-65 years
- •Asthma which requires treatment with guidelines suggested medications for GINA steps 4-5
- •Four or more bursts of systemic corticosteroids >3 days each in the previous year
- •Willingness and ability to give written informed consent
排除标准
- •Current smoker and former smoker > 10 pack years total smoking history
- •Participation in another clinical trial within the prior 4 months
- •Omalizumab therapy within the prior 4 months
- •Allergic bronchopulmonary aspergillosis
- •Patient having had severe exacerbation of their asthma requiring high doses of oral corticosteroids (> 60 mg equivalent prednisolone) more than one month in the previous year
- •Post-bronchodilator FEV1 of less than 30%
- •Past diagnosis of COPD and chronic respiratory insufficiency
- •Known coagulopathy or platelet dysfunction
- •Use of anticoagulants
- •Use of an internal or external pacemaker or internal cardiac defibrillator
- •Contraindication to perform bronchoscopy
- •Contraindication to perform general anesthesia
- •Significant cardiovascular disease
- •Current or recent respiratory tract infection resolved less than 4 weeks
- •Known cancer or cancer history less than 12 months
- •Pregnancy and nursing mother
结局指标
主要结局
Severe exacerbation rate (change from baseline)
时间窗: Baseline, 6 months and 12 months after the last thermoplasty procedure
A severe exacerbation is defined by a burst of systemic corticosteroids \>3 days
次要结局
- Mean oral glucocorticosteroid dose (mg equivalent prednisone)(Baseline, 6 and 12 Months)
- Pre- and post-bronchodilator FEV1(Baseline, 6 and 12 Months)
- Asthma Quality of Life Questionnaire (AQLQ) Score(Baseline, 3, 6, 9 and 12 Months)
- Time to the first severe asthma exacerbation(anytime)
- Mild exacerbation rate(Baseline, 6 and 12 Months)
- Asthma Control Questionnaire (ACQ) Score(Baseline, 3, 6, 9 and 12 Months)
- Structural airway remodeling using CT(Baseline and 12 Months)
- Inflammatory cells and markers in induced sputum(Time Frame: Baseline and 12 Months)
研究者
研究点 (2)
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