Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00455130
Status:
COMPLETED
Last Update Posted:
2010-02-02
First Post:
2007-04-02
Brief Title:
A Phase 2 Study to Determine the Safety and Efficacy of Inhaled Dry Powder Mannitol in Cystic Fibrosis
Sponsor:
Syntara
Organization:
Syntara
Study Overview
Official Title:
None
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:
Cystic fibrosis is the most frequent lethal genetic disease of childhood Causes disruption of glandular function of the pancreas intestine liver lungs causing chronic lung infection with emphysema sweat glands and reproductive organs We know that many CF patients die of lung failure brought about in part by repeated lung infections caused by thick sticky mucus that cannot be readily cleared from the lung
Inhaled mannitol is an osmotic agent that has been investigated in a number of small studies that have examined mucociliary clearance quality of life and lung function in CF and bronchiectasis The promising results of these studies warrant futher investigation The aim of this study is to assess the safety and efficacy of inhaled mannitol when administered twice a day over two weeks in CF
Inhaled mannitol is an osmotic agent that has been investigated in a number of small studies that have examined mucociliary clearance quality of life and lung function in CF and bronchiectasis The promising results of these studies warrant futher investigation The aim of this study is to assess the safety and efficacy of inhaled mannitol when administered twice a day over two weeks in CF
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