A double-blind, randomized, double dummy, cross over, study to assess the difference in efficacy between nebulisation of rhDNase in the morning versus nebulisation before going to sleep.
Completed
- Conditions
- Cystic Fibrosis.
- Registration Number
- NL-OMON20146
- Lead Sponsor
- Roche Nederland BVPO Box 443440 AA WOERDENThe Netherlands
- Brief Summary
Eur Respir J. 2007 Oct;30(4):763-8. Epub 2007 Jun 27.
- 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
Admission:
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pulmonary function test: MEF25.
- Secondary Outcome Measures
Name Time Method 1. Pulmonary function tests: FVC, FEV1, Rint;<br /><br>2. Frequency and duration of coughing measured with audiorecording;<br /><br>3. Oxygenation at night recording transcutaneous oxygen saturation;<br /> percentage with saturation below 95%;<br /><br>4. Severity of cough with a VCD score;<br /><br>5. Sputum characteristics: amount, viscosity with a VAS-score;<br /><br>6. Quality of sleep and appetite with a VAS-score;<br /><br>7. Presence of morning sickness.