Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00393458
Status:
COMPLETED
Last Update Posted:
2011-08-18
First Post:
2006-10-25
Brief Title:
Efficacy Safety and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease COPD Using Formoterol Twice Daily as Active Control
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
A 52-week Treatment Multicenter Randomized Double-blind Double-dummy Placebo-controlled Parallel-group Study to Assess the Efficacy Safety and Tolerability of Indacaterol 300 and 600 µg Once Daily in Patients With Chronic Obstructive Pulmonary Disease Using Formoterol 12 µg Twice Daily as an Active Control
Status:
COMPLETED
Status Verified Date:
2011-07
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:
None
Brief Summary:
This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler SDDPI in patients with chronic obstructive pulmonary disease COPD Patients were randomized to receive either indacaterol 300 µg once daily indacaterol 600 µg once daily formoterol 12 µg twice daily or placebo
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