EUCTR2005-005874-65-BE进行中(未招募)不适用
on-invasive monitoring of airway inflammation in asthmatic patients during adaptation of inhaled steroid therapy
niversity Hospital Antwerp0 个研究点目标入组 40 人开始时间: 2006年1月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Informed consent
- •-Male and female patients between 18 and 65 years
- •-Established diagnosis of asthma at least 3 months before the start of the study and based on: documented reversible airway obstruction of >= 9% of predicted or documented positive metacholine provocation test
- •-Treatment with Symbicort 160/4.5 2*2 during the last 2 months
- •-Clinical stable patients with asthma symptoms < 1 a week, no nocturnal symptoms, PEF variability < 20%
- •-Patients are able to use Symbicort T (and Bricanyl T) correctly
- •-Patients are able to use Peak flow measurements correctly
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Patients with severe cardiovascular disease
- •-Recent upper airway infection (within one month before the start of the study)
- •-Chronic rhino-sinusitis
- •-Use of systemic steroids 30 days before the start of the study
- •-Use of ß blocking agents
- •-Pregnancy and breast feeding during the study
- •-Addiction to alcohol or drugs that may interfere with the overall compliance
- •-Planned surgical interventions during the study period
- •-Concomitant treatment with anticholinergics, theophyllines and LTRA
- •-At visit 2: infections and unstable asthma (symptoms more than 1time a week, nocturnal symptoms, PEF variability of >20%) or upper respiratory tract infection during run-in
研究者
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