EUCTR2004-001888-21-GB进行中（未招募）1 期
A cross-over comparative study of inhaled mannitol, alone and in combination with daily rhDNase, in children with cystic fibrosis - Inhaled Mannitol in Cystic Fibrosis
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 42
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
入选标准
- •1. Confirmed diagnosis of cystic fibrosis (sweat test or genotype)
- •2. Aged between 5 and 18 years
- •3. Have Forced Expiratory Volume in one second (FEV1) <70% of predicted for height, age and gender OR currently taking rhDNase
- •4. Able to perform acceptable-quality spirometry
- •5. Likely to co-operate, take medication as prescribed, and attend the clinic at the appointed times during the study
- •6. Are capable of and have given informed consent to participate in this study in accordance with local regulations
- •7. Clinically stable in the week up to study entry
- •8. No additional antibiotics for a period of 14 days before study entry (routine antibiotics permitted)
- •Are the trial subjects under 18? yes
- •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
- •1. Investigators, site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biologically or legally adopted.
- •2. Subjects with currently active asthma
- •3. Colonised with Burkholderia cepacia
- •4. Considered terminally ill” or listed for transplantation
- •5. Concurrent illnesses - Cor pulmonale, portal hypertension, varices
- •6. Requiring home oxygen or assisted ventilation
- •7. Significant episode of hemoptysis (>60 mL) in the previous 12 months
- •8. Heart attack or stroke in last 3 months
- •9. Known aortic aneurysm
- •10. Subjects who are breast feeding or pregnant.
- •11. At risk females unwilling to use appropriate contraception to prevent pregnancy during the course of the study
- •12. Subjects who have participated in another investigative drug study parallel to, or within 4 weeks of study entry.
- •13. Known intolerance to mannitol, rhDNase or ß agonists.
- •14. Uncontrolled hypertension, systolic BP > 200, or diastolic BP> than 100
研究者
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