Trials / Completed
CompletedNCT00117208
Comparison of Inhaled Mannitol and rhDNase in Children With Cystic Fibrosis
A Cross-Over Comparative Study of Inhaled Mannitol, Alone and in Combination With Daily rhDNase, in Children With Cystic Fibrosis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Syntara · Industry
- Sex
- All
- Age
- 8 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the medium term efficacy and safety profile of inhaled mannitol, on its own and also as an additional therapy to rhDNase (pulmozyme). In particular, we will assess the impact on: lung function; airway inflammation; sputum microbiology; exacerbations; quality of life; adverse events; exercise tolerance; total costs of hospital and community care; and cost-effectiveness.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | mannitol | 400mg BD for 12 weeks |
| DRUG | mannitol + pulmozyme | combination |
| DRUG | Dornase alpha | 2.5mg daily for 2 weeks |
Timeline
- Start date
- 2005-11-01
- Primary completion
- 2008-02-01
- Completion
- 2008-02-01
- First posted
- 2005-07-04
- Last updated
- 2010-02-02
Locations
2 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT00117208. Inclusion in this directory is not an endorsement.