‘Peripheral targeting of inhaled rhDNase in stable CF patients.’

ErasmusMC - Sophia Children's Hospital0 个研究点目标入组 50 人开始时间: 2007年4月2日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•The criteria of inclusion will be the following:
•- Age between 6 and 18 years old;
•- Diagnosis of CF confirmed by sweat-test and/or DNA analysis and/or electro physiology testing (nasal potential difference measurement);
•- Routine treatment with rhDNase once daily, started at least one month before enrolment in the study;
•- Stable condition, in this study defined as: no i.v antibiotics (hospital or at home) in the previous month and constant medication regime during the previous 2 weeks (for example: no additional oral antibiotics course, no newly started inhaled or systemic corticosteroids etc).
•- Ability to perform lung function tests (assessed by trained lung function technician);
•- Lung function: FVC ³ 40% predicted;
•- Signed written informed consent.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years)
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years)
•F.1.3.1 Number of subjects for this age range

•The following exclusion criteria will be used:
•- Inability to follow instructions of the investigator;
•- Inability to inhale rhDNase;
•- Clinical condition not stable, as assessed by the patient’s paediatrician;
•- Concomitant medical conditions that effect inhaled treatment (e.g. cleft palate, severe malacia);
•- Current respiratory tract infection;
•- Pulmonary complications that might put the patient at risk to participate in the study;
•- Neuromuscular disease;
•- Poor compliance with treatment as assessed by the patient’s paediatrician;
•- Active ABPA (allergic bronchopulmonary aspergillosis) defined as an oral course of prednisone for ABPA within the last three months.

发起方

ErasmusMC - Sophia Children's Hospital