Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-01-01 @ 1:03 PM
Study NCT ID:
NCT00918957
Status:
COMPLETED
Last Update Posted:
2012-10-03
First Post:
2009-06-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Tobramycin Inhalation Powder From a Modified Manufacturing Process Versus Placebo
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder From a Modified Manufacturing Process (TIPnew).
Status:
COMPLETED
Status Verified Date:
2012-10
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:
EDIT
Brief Summary:
This study is designed to show how well tobramycin inhalation powder works and how safe it is when produced by a modified manufacturing process
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2008-002318-22 | EUDRACT_NUMBER | None | View |