DIEPTE-study: DNase Inhalation in cf Exacerbations, Peripherally Targeted.
Completed
- Registration Number
- NL-OMON25231
- Lead Sponsor
- Roche Nederland B.V.
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
The criteria of inclusion will be the following:
1. Age between 6 and 18 years old;
Exclusion Criteria
The following exclusion criteria will be used:
1. Inability to follow instructions of the investigator;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease is most prominent in the peripheral airways in CF. Therefore our primary outcome measurement will be focussed on the periphery of the lung, using FEF75 and FEF75-25 (assessed by spirometry). FEF75 and FEF75-25 measured on study day 12 (after 7 days of treatment with Akita) is our primary outcome parameter.
- Secondary Outcome Measures
Name Time Method Secondary outcome measurements will include:<br /><br>1. Other values obtained in the flow volume curve: FVC, FEV1;<br /><br>2. Lung inhomogeneity measurements;<br /> <br>3. Nightly oxygen saturation profile;<br /><br>4. Symptom scores evaluating pulmonary symptoms (e.g. cough, increased sputum);<br /><br>5. Lung function measurements at discharge;<br /><br>6. Lung function measurements on day 5 (end of run-in) and day 6 (first day of treatment with study drug), to assess a possible short-term effect of the peripherally deposited rhDNase.