Cysic Fibrosis.
Conditions
Interventions
The study was a randomized, double blind, double dummy, cross over design. All subjects nebulized daily both rhDNase (2.5 mg of rhDNase in 2.5 ml buffered solution:
8.77 mg/ml sodium chloride and 0.1
Sponsors
Roche Nederland BV
PO box 44
3440 AA WOERDEN
The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: 1. Proven CF, as evidenced by an abnormal sweat test or an abnormal rectum potential difference measurement or by the presence of two CF mutations and at least one clinical feature of CF; 2. Treated at the Erasmus MC - Sophia, and a. Five years or older; b. Able to perform reproducible manoeuvres for spirometry; c. Carrying out daily CPT; d. Maintenance treatment with rhDNase for at least one month; e. Clinically stable for at least one month (no intravenous antibiotics and / or hospitalizations within one month before enrolment); 4. Willing to participate in and comply with study procedures, and willingness of the parent or guardian and of the subjects >12 years to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Using rhDNase more than once daily; 2. Mental retardation; 3. Having a history of non-adherence to treatment advice known to the physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulmonary function tests: MEF25. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pulmonary function tests: FVC, FEV1, Rint; 2. Severity of cough with a VCD score; 3. Sputum characteristics: amount, viscosity with a VAS-score. | — |
Contacts
Public ContactLianne Giessen, van der
Erasmus Medical Center, Sophia Children's Hospital, Department Pediatric Physiotherapy, SK 0327, Dr Molewaterplein 60
Outcome results
None listed