NL-OMON34039已完成3 期
Peripheral targeting of inhaled rhDNase for chronic obstructive asthma in childhood. - IDOL (Inhaled DNase in Asthmatic children with Obstructive Lung function)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17（—）
入选标准
- •Age 6 - 18 years;
- •Asthma diagnosed according to GINA guidelines;
- •Treatment with at least 400 microg/day inhaled Budesonide or equivalent (dose constant for at least 6 months) and bronchodilators as needed or daily;
- •Clinically stable asthma while using a constant dose of inhaled corticosteroids (ICS);
- •Persistent peripheral airways obstruction as assessed by pulmonary function testing, defined as:
- •o Dissociation between FVC and FEF75 values: FEF75 at least 20% (absolute % predicted) lower than FVC. ;FVC within normal limits (for this study defined as FVC > 80% pred).
排除标准
- •Asthma exacerbation with hospital admission in last 3 months;
- •Intensive Care Unit (ICU) admission for asthma in last year;
- •Current respiratory tract infection;
- •Inability to follow instructions of the investigator;
- •Inability to inhale rhDNase;
- •Concomitant medical conditions that effect inhaled treatment (e.g. cleft palate, severe airway malacia);
- •Neuromuscular disease;
研究者
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