Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00499720
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2011-08-02
First Post:
2007-07-09
Brief Title:
Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
Expanded Access Program for Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection Who Have Limited Treatment Options and Are at Risk for Disease Progression
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this program is to provide expanded access to aztreonam lysine for inhalation AZLI 75 mg prior to its commercial availability to patients with cystic fibrosis CF and chronic P aeruginosa airway infection who have limited treatment options and are at risk for disease progression
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