NL-OMON33580
Completed
Not Applicable
Peripheral targeting of inhaled rhDNase in stable CF patients. - PIPES-study (Pulmozyme Inhalation to the PEripheral airways in Stable CF.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cystic Fibrosis (CF)
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 25
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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