A pilot randomised controlled trial to assess the impact of Target Inhalation Mode (TIM) aerosol delivery on the treatment time with nebulised antibiotic therapy in children with Cystic Fibrosis

Alder Hey Children's NHS Foundation Trust (UK)0 个研究点目标入组 20 人开始时间: 2011年4月7日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Patients with a valid diagnosis (sweat chloride > 60 or two CF causing gene mutations)
•2. Airway infection with Pseudomonas aeruginosa requiring long term nebulised Colistin therapy
•3. Established on standard Tidal Breathing Mode of delivery using AAD device for Colistin therapy
•4. Ability to comprehend use of the TIM device and follow instruction
•5. Aged more than or equal to 5 years and able to perform lung function
•6. No recent (> 6 weeks) exacerbation of chest condition as defined by
•6.1. A deterioration forced expiratory volume in one second (FEV1) more than or equal to 10% from previously recorded value
•6.2. Cough
•6.3. Change in sputum production

•1. Patient with first growth of Pseudomonas aeruginosa requiring short term (3 months) colistin therapy
•2. Patients prescribed alternate month TOBI and Colistin nebulised therapy
•3. Patients with an acute exacerbation respiratory symptoms

发起方

Alder Hey Children's NHS Foundation Trust (UK)