Phase 4 Study of the Efficacy of Long-term Treatment With Hypertonic Saline on Pulmonary Exacerbations in Patients With Cystic Fibrosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Free time, specified in days, of pulmonary exacerbation
研究概览
简要总结
A phase IV clinical trial, multicentric (3 Hospitals in Madrid) controlled, prospective, open and randomized of long-term treatment with hypertonic saline in cystic fibrosis patients. The purpose of this study is to verify if the long term inhalation (48 weeks) of major volume (10 ml) increases the free time without pulmonary exacerbation, and if this increase is superior to the obtained with the inhalation of the standard volume (5 ml) that has been advocated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Cystic fibrosis
- •Over 6 years old
- •FEV1 over than 30%
- •Must be able to perform a spirometry
- •Must be able to perform induced sputum
- •Must tolerate the maximum dose of 10 ml hypertonic saline
- •No oral neither intravenous treatment within the previous 2 weeks before the beginning of the study
- •No treatment with hypertonic saline in the 2 weeks before
排除标准
- •No clinical diagnosis of Cystic Fibrosis
- •No tolerance of 10 ml of hypertonic saline
- •Positive pregnancy test
- •No tolerance of Beta2-agonist
- •Treatment with corticosteroids
- •FEV1 < 30%
- •Liver and/or lung transplantation
- •Oxygen treatment
- •Hospital admission within the 4 previous weeks
- •Oral or intravenous antibiotic treatment within the 2 previous weeks
- •Pulmonary colonisation with Burkholderia cepacia complex
研究组 & 干预措施
5 ml
干预措施: Hypertonic saline (Drug)
10 ml
干预措施: Hypertonic saline (Drug)
结局指标
主要结局
Free time, specified in days, of pulmonary exacerbation
时间窗: 12 months
Exact number of days, along 48 weeks of tretment with hypertonic saline, in wich the patient is free of pulmonary excaerbation symptoms and does not need antibiotics.
次要结局
- Changes in lung function test measured by spirometry(12 months)
- Changes in inflammatory markers during the treatment(12 months)
- Quality of life(12 months)
研究者
Adelaida Lamas Ferreiro
Dra.Adelaida Lamas Ferreiro
Hospital Universitario Ramon y Cajal