Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128492
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2005-08-08
Brief Title:
Safety and Efficacy Study of Aztreonam for Inhalation Solution AZLI in Cystic Fibrosis CF Patients With Pseudomonas Aeruginosa PA
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
A Phase 3 Open-label Follow-On Study of Multiple Courses of Aztreonam Lysinate for Inhalation AI in Cystic Fibrosis Patients AIR-CF3
Status:
COMPLETED
Status Verified Date:
2011-05
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:
AIR-CF3
Brief Summary:
The purpose of this study was to evaluate the safety and efficacy of multiple courses of AZLI in patients with cystic fibrosis CF and lung infection due to Pseudomonas aeruginosa PA
Detailed Description:
People with CF often have lung infections that occur repeatedly or worsen over time The lung infections are often caused by PA Treatment with antibiotics is used to reduce the presence of the bacteria The antibiotics may be given orally intravenously or inhaled as a mist The purpose of this study was to evaluate whether AZLI an investigational formulation of the antibiotic aztreonam is safe in repeated courses in patients with CF and PA
A course of AZLI treatment in this study comprised 28 days followed by a 28-day period off treatment Participants could receive up to 9 courses of AZLI with a total time on study of up to 18 months Safety and efficacy results for the 18-month 9-course period are reported with efficacy results presented on a by-treatment course basis
A course of AZLI treatment in this study comprised 28 days followed by a 28-day period off treatment Participants could receive up to 9 courses of AZLI with a total time on study of up to 18 months Safety and efficacy results for the 18-month 9-course period are reported with efficacy results presented on a by-treatment course basis
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