NL-OMON33580已完成不适用
Peripheral targeting of inhaled rhDNase in stable CF patients. - PIPES-study (Pulmozyme Inhalation to the PEripheral airways in Stable CF.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
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
- •The criteria of inclusion will be the following:
- •- Age between 6 and 18 years old;
- •- Diagnosis of CF confirmed by sweat-test and/or DNA analysis and/or electro physiology testing (nasal potential difference measurement);
- •- Routine treatment with rhDNase once daily, started at least one month before enrolment in the study;
- •- Stable condition, in this study defined as: condition of patient judged to be stable by the treating physician AND no i.v antibiotics (hospital or at home) in the previous month and constant medication regime during the previous 2 weeks (for example: no additional antibiotics course, no newly started inhaled or systemic corticosteroids etc).
- •- Ability to perform lung function tests (assessed by trained lung function technician);
- •- Lung function: FVC > 40% predicted;
- •- Signed written informed consent.
排除标准
- •The following exclusion criteria will be used:
- •- Inability to follow instructions of the investigator;
- •- Inability to inhale rhDNase;
- •- Concomitant medical conditions that effect inhaled treatment (e.g. cleft palate, severe malacia);
- •- Current respiratory tract infection;
- •- Pulmonary complications that might put the patient at risk to participate in the study;
- •- Neuromuscular disease;
- •- Poor compliance with treatment as assessed by the patient*s paediatrician;
- •- Active ABPA (allergic bronchopulmonary aspergillosis) defined as an oral course of prednisone for ABPA within the last three months.
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