Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-27 @ 8:10 AM
Study NCT ID:
NCT00784550
Status:
COMPLETED
Last Update Posted:
2016-11-23
First Post:
2008-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A 24-Week Study to Evaluate the Safety and Efficacy of ADVAIR DISKUS® Inhaler 250/50mcg Plus SPIRIVA HANDIHALER® Inhaler Versus SPIRIVA HANDIHALER® Inhaler Plus Placebo DISKUS® Inhaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD).
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Parallel-Group, 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR DISKUS (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder 18mcg) QD Versus Spiriva QD Plus Placebo DISKUS BID in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Status:
COMPLETED
Status Verified Date:
2016-10
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:
ADC111114
Brief Summary:
The purpose of the study is to determine the efficacy and safety of the combination of ADVAIR DISKUS® 250/50mcg (FLUTICASONE PROPIONATE/SALMETEROL COMBINATION PRODUCT) plus SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) compared to SPIRIVA® HANDIHALER® inhaler 18mcg (TIOTROPIUM) in patients with COPD.
SPIRIVA® and HANDIHALER® are trade marks of Boehringer Ingelheim Pharma GmbH \& Co. KG.
ADVAIR DISKUS® are registered trademarks of the GSK group of companies.
SPIRIVA® and HANDIHALER® are trade marks of Boehringer Ingelheim Pharma GmbH \& Co. KG.
ADVAIR DISKUS® are registered trademarks of the GSK group of companies.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: