Peripheral targeting of inhaled rhDNase in stable CF patients. - PIPES-study (Pulmozyme Inhalation to the PEripheral airways in Stable CF.

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 25 人开始时间: 待定最近更新: 2024年5月13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: condition of patient judged to be stable by the treating physician AND 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 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 > 40% predicted;
•- Signed written informed consent.

•The following exclusion criteria will be used:
•- Inability to follow instructions of the investigator;
•- Inability to inhale rhDNase;
•- 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.

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