Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104520
Status:
COMPLETED
Last Update Posted:
2011-03-11
First Post:
2005-03-01
Brief Title:
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 Randomized Placebo-Controlled Trial With Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary P Aeruginosa Requiring Frequent Antibiotics AIR-CF2
Status:
COMPLETED
Status Verified Date:
2010-09
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-CF2
Brief Summary:
The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution AZLI in patients with cystic fibrosis CF and lung infection due to Pseudomonas aeruginosa PA
Detailed Description:
Patients with CF often have lung infections that occur repeatedly or worsen over time The lung infections are often caused by a bacteria called 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 aztreonam for inhalation solution AZLI an investigational formulation of the antibiotic administered using the eFlow Electronic Nebulizer by PARI GmbH in CF patients with PA
In this study participants were screened for eligibility at Visit 1 Day -42 and returned to the center for Visit 2 after a 14-day evaluation period At Visit 2 Day -28 participants began a 28-day course of open-label Tobramycin Inhalation Solution TIS At Visit 3 Day 0 following completion of the 28-day course of TIS participants began randomized blinded treatment with either AZLI twice a day BID or three times a day TID or placebo BID or TID and continued treatment for a total of 28 days with a clinic visit at Day 14 Visit 4 and at the end of treatment Visit 5 Day 28 Participants returned for visits every 2 weeks for 8 weeks after the end of the blinded treatment Visits 6 to 9 Days 42 to 84
Two hundred and forty-seven participants were treated in the TIS phase of this study Two hundred and eleven subjects completed the TIS phase and were treated in the placebo-controlled phase with study drug AZLI or placebo
In this study participants were screened for eligibility at Visit 1 Day -42 and returned to the center for Visit 2 after a 14-day evaluation period At Visit 2 Day -28 participants began a 28-day course of open-label Tobramycin Inhalation Solution TIS At Visit 3 Day 0 following completion of the 28-day course of TIS participants began randomized blinded treatment with either AZLI twice a day BID or three times a day TID or placebo BID or TID and continued treatment for a total of 28 days with a clinic visit at Day 14 Visit 4 and at the end of treatment Visit 5 Day 28 Participants returned for visits every 2 weeks for 8 weeks after the end of the blinded treatment Visits 6 to 9 Days 42 to 84
Two hundred and forty-seven participants were treated in the TIS phase of this study Two hundred and eleven subjects completed the TIS phase and were treated in the placebo-controlled phase with study drug AZLI or placebo
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