Is Dornase alfa (Pulmozyme ) effective if administered at night, in relation to airways clearance techniques? A multi centre, crossover, randomised controlled trial for people with cystic fibrosis.
Phase 4
Completed
- Conditions
- Cystic Fibrosis (CF)Human Genetics and Inherited Disorders - Cystic fibrosis
- Registration Number
- ACTRN12607000155493
- Lead Sponsor
- Royal Children's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 46
Inclusion Criteria
With CF attending outpatient clinics; using rhDNase (Pulmozyme); able to perform spirometry; with stable lung disease as assessed by physician at the time of the study; not currently participating in another clinical trial. Stable lung disease was defined as no deterioration in symptoms and no change in chest management for one month (Henry et al, 1998). Patients were excluded if they were currently enrolled in another study or had significant comorbidities (eg unstable diabetes).
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method