Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00446680
Status:
COMPLETED
Last Update Posted:
2010-06-25
First Post:
2007-03-12
Brief Title:
Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis - A Safety and Efficacy Study
Sponsor:
Syntara
Organization:
Syntara
Study Overview
Official Title:
Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis - A Safety and Efficacy Study
Status:
COMPLETED
Status Verified Date:
2010-06
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 efficacy and safety of chronic treatment with inhaled dry powder mannitol in subjects with cystic fibrosis Previous studies have demonstrated an improvement in lung function related to small airways obstruction and a significant improvement in respiratory symptoms and quality of life after a 2 week treatment with mannitol This current study seeks to support these early findings and to extend the evidence to support its use as a mucoactive therapy in cystic fibrosis In particular the hypothesis that enhanced mucus clearance will improve the lung function and clinical presentation in this population will be investigated We also hypothesize that enhanced mucociliary clearance will result in a sustained reduction in mucus load thus providing less opportunity for bacteria to proliferate affording a reduction in antibiotic use and hospitalizations The initial 6 month blinded phase will be followed with an additional 6 months of open label treatment
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