Peripheral targeting of inhaled recombinant human deoxyribonuclease in stable cystic fibrosis patients

Erasmus Medical Centre (The Netherlands)0 个研究点目标入组 50 人开始时间: 2007年3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. Age between six and 18 years old
•2. Diagnosis of CF confirmed by sweat-test and/or deoxyribonucleic acid (DNA) analysis and/or electro-physiology testing (nasal potential difference measurement)
•3. Routine treatment with rhDNase once daily, started at least one month before enrolment in the study
•4. Stable condition, in this study defined as: no intravenous (i.v.) antibiotics (hospital or at home) in the previous month and constant medication regime during the previous two weeks (for example: no additional oral antibiotics course, no newly started inhaled or systemic corticosteroids etc.,)
•5. Ability to perform lung function tests (assessed by trained lung function technician)
•6. Lung function: forced vital capacity (FVC) greater than 40% predicted
•7. Signed written informed consent

•1. Inability to follow instructions of the investigator
•2. Inability to inhale rhDNase
•3. Clinical condition not stable, as assessed by the patient?s paediatrician
•4. Concomitant medical conditions that effect inhaled treatment (e.g. cleft palate, severe malacia)
•5. Current respiratory tract infection
•6. Pulmonary complications that might put the patient at risk to participate in the study
•7. Neuromuscular disease
•8. Poor compliance with treatment as assessed by the patient?s paediatrician
•9. Active allergic bronchopulmonary aspergillosis (ABPA) defined as an oral course of prednisone for ABPA within the last three months

发起方

Erasmus Medical Centre (The Netherlands)