Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112359
Status:
COMPLETED
Last Update Posted:
2011-04-21
First Post:
2005-06-01
Brief Title:
International Safety and Efficacy Study of Aztreonam for Inhalation Solution AZLI in Cystic Fibrosis Patients With P Aeruginosa
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
A Phase 3 Double-Blind Multicenter Multinational Randomized Placebo-Controlled Trial Evaluating Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary Pseudomonas Aeruginosa AIR-CF1
Status:
COMPLETED
Status Verified Date:
2011-03
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-CF1
Brief Summary:
The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution AZLI in patients with cystic fibrosis CF and lung infection due to Pseudomonas aeruginosa PA
Detailed Description:
CF patients often have lung infections that occur repeatedly or worsen over time The lung infections are often caused by a bacteria called Pseudomonas aeruginosa PA Treatment with antibiotics can stop or slow down the growth of the bacteria The antibiotics may be given by mouth intravenously IV or by inhalation as a mist The purpose of this study was to evaluate the safety and efficacy of AZLI an investigational formulation of the antibiotic aztreonam and administered TID using the PARI eFlow electronic nebulizer in CF patients with PA
In this study participant eligibility was assessed at a screening visit 7 to 14 days prior to the baseline visit Day 0 Those participants who continued to meet eligibility criteria at Day 0 were randomized and began a 28-day course of blinded study treatment AZLI TID or placebo TID Participants returned for clinic visits at Day 14 an end of treatment visit at Day 28 and a follow-up visit 14 days after the last dose of study drug Day 42
In this study participant eligibility was assessed at a screening visit 7 to 14 days prior to the baseline visit Day 0 Those participants who continued to meet eligibility criteria at Day 0 were randomized and began a 28-day course of blinded study treatment AZLI TID or placebo TID Participants returned for clinic visits at Day 14 an end of treatment visit at Day 28 and a follow-up visit 14 days after the last dose of study drug Day 42
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