Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00277537
Status:
COMPLETED
Last Update Posted:
2008-08-29
First Post:
2006-01-13
Brief Title:
Safety and Efficacy of Bronchitol in Bronchiectasis
Sponsor:
Syntara
Organization:
Syntara
Study Overview
Official Title:
A Phase III Multicenter Randomised Parallel Placebo-Controlled Double-Blind Study to Investigate the Safety and Efficacy of Treatment With Bronchitol Dry Powder Mannitol in the Symptomatic Treatment of Bronchiectasis
Status:
COMPLETED
Status Verified Date:
2008-08
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:
Study will assess the safety and effectiveness of 12 week treatment with the study medication Bronchitol in subjects with bronchiectasis a lung disease where patients have trapped and often infected thick sticky mucus Past studies have shown Bronchitol inhalation may help to facilitate the clearance of mucus by altering its rheology making it less thick and sticky thereby enhancing the shift of stagnant mucus from the lungs On completion of the double blind phase subjects will have the opportunity to participate in a 52 week open label phase
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