A double-blind, randomised, double dummy, cross over, study to assess the difference in efficacy between nebulisation of rhDNase before airway clearance therapy (ACT) versus nebulisation after ACT
- Conditions
- Cystic Fibrosis (CF)Nutritional, Metabolic, EndocrineCystic Fibrosis
- Registration Number
- ISRCTN87248226
- Lead Sponsor
- Roche Nederland BV (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 25
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:
2.1. Five years or older
2.2. Able to perform reproducible manoeuvres for spirometry
2.3. Carrying out daily CPT
2.4. Maintenance treatment with rhDNase for at least one month
2.5. Clinically stable for at least one month (no intravenous antibiotics and/or hospitalisations within one month before enrolment)
3. 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
1. Using rhDNase more than once daily
2. Mental retardation
3. Having a history of non-adherence to treatment advice known to the physician
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: <br>1.1. Forced vital capacity (FVC)<br>1.2. Forced expiratory volume in one second (FEV1)<br>1.3. Rint<br>2. Severity of cough with a VCD score<br>3. Sputum characteristics: amount, viscosity with a visual analogue scale (VAS)