NCT01185275已完成不适用
A Prospective Observational Study of Biopredictors of Bronchial Thermoplasty Response in Patients With Severe Refractory Asthma (BTR Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 8
- 主要终点
- Baseline predictors of response to bronchial thermoplasty defined by improvement in asthma quality of life, in patients with severe refractory asthma.
研究概览
简要总结
Clinical response, as defined by improvement in asthma quality of life, to bronchial thermoplasty in patients with severe refractory asthma can be predicted through the use of clinical, physiologic, biologic and imaging markers.
详细描述
Primary Aim To assess the relationship between baseline clinical, physiologic, biologic and imaging markers and response to bronchial thermoplasty, defined by improvement in asthma quality of life, in patients with severe refractory asthma.
Secondary Aims
- To assess the relationship between baseline clinical, physiologic, biologic and imaging markers and response to bronchial thermoplasty, defined by reduction in severe exacerbations or healthcare utilization, in patients with severe refractory asthma.
- To evaluate if baseline clinical, physiologic, biologic and imaging markers are related to safety of bronchial thermoplasty in patients with severe refractory asthma.
- To evaluate and validate statistical models that predict response to bronchial thermoplasty in patients with severe refractory asthma.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females age 18 or greater and less than 65
- •Subject has asthma and is taking regular maintenance medication for past 12 months that includes:
- •Inhaled corticosteroid (ICS) at a dosage greater than 1000μg beclomethasone per day or equivalent, AND long acting ß2-agonist (LABA) at a dosage of ≥100μg per day Salmeterol or equivalent.
- •Other asthma medications such as leukotriene modifiers, or anti-IgE, are acceptable (Subjects on Xolair® must have been on Xolair for greater than 1 year).
- •Asthma confirmed by: (a) b-agonist reversibility of FEV1 ≥ 12 % following 360mcg albuterol OR (b) methacholine FEV1 PC20 ≤ 8 mg/ml if not receiving an ICS or ≤ 16 mg/ml if receiving an ICS.
- •FEV1 ≥ 50% predicted pre-bronchodilator.
- •Asthma symptoms on at least two days or one night per week over the last 2 weeks.
- •Subject is a non-smoker for 1 year or greater (if former smoker, less than 10 pack years total smoking history).
- •Ability to undergo bronchoscopy in the opinion of the investigator.
- •Ability and willingness to provide informed consent.
排除标准
- •Asthma exacerbation (ED visit, hospitalization, course of increased systemic steroids, or urgent health care visit for asthma) during the prior four weeks.
- •Subject has 3 or more hospitalizations for exacerbations of asthma in the previous year or 1 or more ICU admission for asthma in the previous year.
- •Chronic oral steroid therapy greater than 30 mg per day
- •Subject has other respiratory diseases including interstitial lung disease, emphysema, cystic fibrosis, vocal cord dysfunction, mechanical upper airway obstruction, untreated obstructive sleep apnea, Churg-Strauss syndrome, cardiac dysfunction, and allergic bronchopulmonary aspergillosis (total IgE of >1000 Units/mL with positive specific IgE to aspergillus and evidence of central bronchiectasis) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation.
- •Subject has segmental atelectasis, lobar consolidation, significant or unstable pulmonary infiltrate, or pneumothorax, confirmed on x-ray.
- •Subject has clinically significant cardiovascular disease, including myocardial infarction, angina, cardiac dysrhythmia, conduction defect, cardiomyopathy, aortic aneurysm, or stroke.
- •Subject has uncontrolled hypertension (>200mm Hg systolic or >100mm Hg diastolic pressure).
- •Subject uses an internal or external pacemaker or cardiac defibrillator.
- •Chronic diseases (other than asthma) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation, e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, or nervous system, or immunodeficiency
- •History of cigarette smoking with > 10 pack years total
- •Use of investigative drugs or intervention trials in the 30 days prior to enrollment or during the duration of the study
- •Any condition or compliance issue which in the opinion of the investigator might interfere with participation in the study
结局指标
主要结局
Baseline predictors of response to bronchial thermoplasty defined by improvement in asthma quality of life, in patients with severe refractory asthma.
时间窗: 12 months following last bronchial thermoplasty treatment
To assess the relationship between baseline clinical, physiologic, biologic and imaging markers and response to bronchial thermoplasty, defined by improvement in asthma quality of life, in patients with severe refractory asthma.
次要结局
- Baseline predictors of severe exacerbations(12 months following last bronchial thermoplasty treatment)
- Baseline predictors of safety of bronchial thermoplasty(12 months following last bronchial thermoplasty treatment)
- Predictive models of response to bronchial thermoplasty(12 months following last bronchial thermoplasty treatment)
- Baseline predictors of healthcare utilization(12 months following last bronchial thermoplasty treatment)
研究者
研究点 (8)
Loading locations...
相似试验
已完成
不适用
Clinical efficacy of bronchial thermoplasty for severe bronchial asthmaBronchial asthmaJPRN-UMIN000044207Osaka Red Cross Hospital21
招募中
不适用
Spirometric Response to Bronchial Thermoplasty in Patients With Severe AsthmaAsthmaNCT02241265University of Oklahoma20
已完成
不适用
Effectiveness and safety of bronchial thermoplasty in the treatment with severe persistent bronchial asthmaBronchial asthmaJPRN-UMIN000018140Department of Respiratory Medicine, National Center for Global Health and Medicine30
已完成
不适用
Bronchial Thermoplasty for Severe Asthma With Dynamic HyperinflationHyperinflationAsthmaNCT02618551University Hospital, Toulouse14
Unknown
不适用
Bronchial Thermoplasty in Severe Asthma With Frequent ExacerbationsAsthmaNCT02464995University Hospital, Strasbourg, France34