Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424268
Status:
COMPLETED
Last Update Posted:
2016-12-05
First Post:
2007-01-18
Brief Title:
Effect of Roflumilast in Chronic Obstructive Pulmonary Disease COPD Patients Treated With Tiotropium The HELIOS Study BY217M2-128
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Effect of Roflumilast in COPD Patients Treated With Tiotropium A 24-week Double-blind Study With 500 µg Roflumilast Once Daily Versus Placebo The HELIOS Study
Status:
COMPLETED
Status Verified Date:
2016-09
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:
HELIOS
Brief Summary:
The aim of the study is to compare the efficacy of roflumilast to placebo on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease COPD during concomitant administration of tiotropium The study duration will last up to 28 weeks The study will provide further data on safety and tolerability of roflumilast
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-004508-37 | EUDRACT_NUMBER | None | None |