Status:
COMPLETED
Comparison of Inhaled Mannitol and rhDNase in Children With Cystic Fibrosis
Lead Sponsor:
Syntara
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
8-18 years
Phase:
PHASE2
Brief 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 a...
Eligibility Criteria
Inclusion
- Known diagnosis of cystic fibrosis (sweat test or genotype)
- Of either gender
- Aged between 8 and 18 years
- Have a baseline FEV1 of \<70% of the predicted normal value
- Currently taking rhDNase for at least 4 weeks
Exclusion
- Currently active asthma, uncontrolled hypertension, colonised with Burkholderia cepacia or MRSA
- Listed for transplantation
- Known intolerance to mannitol, rhDNase or bronchodilators
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00117208
Start Date
November 1 2005
End Date
February 1 2008
Last Update
February 2 2010
Active Locations (2)
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1
Great Ormond Hospital for Children
London, United Kingdom
2
Royal Brompton Hospital
London, United Kingdom