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临床试验/NCT01749644
NCT01749644Unknown不适用

Switching From Tobramycin Inhalation Treatment to Tobramycin Inhaler Treatment: The Effect on CF Patients' Adherence and Quality of Life

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Improvement in quality of life

研究概览

简要总结

Pseudomonas is a common and virulent respiratory bacteria in patients with Cystic Fibrosis (CF). With time, the infection with Pseudomonas becomes chronic and very difficult to eradicate. The standard treatment of chronic Pseudomonas infection is inhaled Tobramycin which is given every other month.. Inhalation of Tobramycin was proven as an effective treatment that improves the respiratory function and reduces the concentration of bacteria in the sputum. However, inhaled treatment lasts between 15 to 30 minutes twice a day and therefore adherence is a major problem. The effect of switching from inhalation treatment to inhaler treatment on patient's adherence and quality of life has not been studied.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

入选标准

  • Age 6 years and above, Chronic Pseudomonas infection

排除标准

  • Younger than 6 years; No chronic PSeudomonas infection

结局指标

主要结局

Improvement in quality of life

时间窗: 1 year

次要结局

  • Difference in exacerbation events(1 year)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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