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临床试验/NCT00753987
NCT00753987已完成1 期

Tolerability of Hypertonic Saline in Infants With Cystic Fibrosis

The Hospital for Sick Children1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2006年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
13
试验地点
1
主要终点
Decrease in FEV0.5 After Inhalation of Hypertonic Saline

研究概览

简要总结

The objective of the study is to determine whether or not inhalation of hypertonic saline will be tolerated by infants with cystic fibrosis and the effect of inhalation on their lung function.

详细描述

Cystic fibrosis lung disease is characterized by mucous retention which favors secondary bacterial infection and inflammation, which leads to lung damage and ultimately respiratory failure. Classically, therapeutic interventions are aimed to improve mucociliary clearance, to reduce both bacterial load and lower airway inflammation.

Hypertonic saline (HS) has been used for the induction of sputum production in all age groups to obtain secretions from the lower respiratory for diagnostic purposes. Hypertonic saline is also used in older children with CF, who do not produce sputum spontaneously, to obtain representative samples for microbiology.

There is evidence from studies in patients with cystic fibrosis that HS can improve mucociliary clearance. The improvement was more impressive in areas that were well ventilated, making it likely that HS will work better in patients with relatively preserved pulmonary function. Newer evidence also suggests that the osmotic effect on the airway surface that was expected to be short lived, may actually persist for longer time periods (up to 8 hours). All these data indicate that HS may be a useful agent in the treatment of CF patients.

As the effect on mucociliary clearance was found to be better in areas with adequate ventilation, it is logical to assume that treatment with HS may be most efficacious when initiated early in the disease process. So far, no data on the tolerability of inhalation of HS are available for infants with cystic fibrosis. However, evidence from infants with AIDS as well as recent studies in infants with bronchiolitis suggest that hypertonic saline can be safely administered by inhalation in infants. Nevertheless, proof of tolerability in CF infants is a prerequisite for longer term studies of HS in this age group. In older children, tolerability has been tested by measuring pulmonary function both before and after inhalation of HS saline. Similar data are not yet available for infants.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
2 Months 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Confirmed diagnosis of cystic fibrosis
  • Age 2 months to 2 years
  • Routinely scheduled infant pulmonary function test.
  • Clinical stability (no respirator tract infection for 4 weeks prior to study

排除标准

  • Acute respiratory symptoms
  • Wheezing at the time of study
  • Supplemental oxygen therapy
  • Oxygen saturation < 95 % on room air

研究组 & 干预措施

Tolerability of 7% hypertonic saline

Experimental

Administration of a single dose of 7% hypertonic saline

干预措施: Hypertonic Saline (Drug)

结局指标

主要结局

Decrease in FEV0.5 After Inhalation of Hypertonic Saline

时间窗: 100 minutes

Number of participants with a decrease in FEV0.5 by 0% or more after inhalation of hypertonic saline. The number of participants with a change in FEV0.5 of \*more than\* 0% is reported.

次要结局

  • Oxygen Saturation Below 92%(10 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Felix Ratjen

Division Head, Respiratory Medicine

The Hospital for Sick Children

研究点 (1)

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