Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134979
Status:
COMPLETED
Last Update Posted:
2011-10-25
First Post:
2005-07-26
Brief Title:
Formoterol Certihaler Tiotropium HandiHaler and Tiotropium HandiHaler in Combination With Formoterol Certihaler in Patients With Stable Chronic Obstructive Pulmonary Disease
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Efficacy and Safety of Formoterol Certihaler Tiotropium HandiHaler and Tiotropium HandiHaler in Combination With Formoterol Certihaler in Patients With Stable Chronic Obstructive Pulmonary Disease
Status:
COMPLETED
Status Verified Date:
2011-10
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:
None
Brief Summary:
This study is not being conducted in the United States
This study is designed to provide efficacy and safety data for formoterol 10µg twice-a-day bid delivered by the Certihaler in patients with chronic obstructive pulmonary disease COPD This study is also designed to compare the efficacy and safety of therapy with formoterol Certihaler10µg bid added to tiotropium HandiHaler 18µg once daily od compared with tiotropium HandiHaler 18µg od monotherapy and to compare the safety and efficacy of formoterol 10µg bid Certihaler with tiotropium 18µg od HandiHaler
This study is designed to provide efficacy and safety data for formoterol 10µg twice-a-day bid delivered by the Certihaler in patients with chronic obstructive pulmonary disease COPD This study is also designed to compare the efficacy and safety of therapy with formoterol Certihaler10µg bid added to tiotropium HandiHaler 18µg once daily od compared with tiotropium HandiHaler 18µg od monotherapy and to compare the safety and efficacy of formoterol 10µg bid Certihaler with tiotropium 18µg od HandiHaler
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