ISRCTN74815264已完成未知
A double-blind, randomised, double dummy, cross-over, study to assess the difference in efficacy between nebulisation of rhDNase in the morning versus nebulisation before going to sleep
Roche Nederland BV (Netherlands)0 个研究点目标入组 25 人开始时间: 2005年12月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 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
- 性别
- All
入选标准
- •1. Proven cystic fibrosis (CF), as evidenced by an abnormal sweat test or an abnormal rectum potential difference measurement or by the presence of two CF mutations and at least one clinical feature of CF
- •2. Treated at the Erasmus Medical Centre - Sophia
- •3. Five years and older
- •4. Able to perform reproducible manoeuvres for spirometry
- •5. Maintenance treatment with rhDNase for at least one month
- •6. Clinically stable for at least one month (no intravenous antibiotics and/or hospitalisations within one month before enrolment)
- •7. Willing to participate in and comply with study procedures, and willingness of the parent or guardian and subjects greater than 12 years to provide written informed consent
排除标准
- •1. Forced vital capacity (FVC) less than 40%
- •2. Using rhDNase more than once daily
- •3. Mentally retarded
- •4. History of non-adherence to treatment advice known to the physician
研究者
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不适用
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