Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125346
Status:
TERMINATED
Last Update Posted:
2011-10-12
First Post:
2005-07-28
Brief Title:
Tobramycin Inhalation Powder TIP in Cystic Fibrosis Subjects
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Multicenter Phase 3 Trial to Assess the Efficacy and Safety of Tobramycin Inhalation Powder TIP in Cystic Fibrosis CF Subjects
Status:
TERMINATED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
per Data Monitoring Committee recommendation
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVOLVE
Brief Summary:
Lung infections are a chronic problem for patients with cystic fibrosis CF Some patients with CF may have a type of bacteria called Pseudomonas aeruginosa in their lungs that can cause infections or make their symptoms worse Tobramycin inhalation solution TOBI is an approved antibiotic which is inhaled directly into the lungs and can be used to manage these infections Tobramycin inhalation powder TIP is a new experimental powder formulation of tobramycin that is inhaled directly into the lungs using a T-326 inhaler The purpose of this research study is to determine if TIP is safe and effective when compared to placebo a powder with no medicine treatment
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