Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00117208
Status:
COMPLETED
Last Update Posted:
2010-02-02
First Post:
2005-06-30
Brief Title:
Comparison of Inhaled Mannitol and rhDNase in Children With Cystic Fibrosis
Sponsor:
Syntara
Organization:
Syntara
Study Overview
Official Title:
A Cross-Over Comparative Study of Inhaled Mannitol Alone and in Combination With Daily rhDNase in Children With Cystic Fibrosis
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None