A double-blind, randomized, double dummy, cross over, study to assess the difference in efficacy between nebulisation of rhDNase before airway clearande therapy (ACT)versus nebulisation after ACT.
Completed
- Conditions
- Cysic Fibrosis.
- Registration Number
- NL-OMON25167
- Lead Sponsor
- Roche Nederland BVPO box 443440 AA WOERDEN The Netherlands
- Brief Summary
Pediatr Pulmonol. 2007 Jul;42(7):624-30. <br><br> Eur Respir J. 2007 Oct;30(4):763-8. Epub 2007 Jun 27.<br>
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
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
Exclusion Criteria
1. Using rhDNase more than once daily;
2. Mental retardation;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pulmonary function tests: MEF25.
- Secondary Outcome Measures
Name Time Method 1. Pulmonary function tests: FVC, FEV1, Rint;<br /><br>2. Severity of cough with a VCD score;<br /><br>3. Sputum characteristics: amount, viscosity with a VAS-score.