Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT00297102
Status:
COMPLETED
Last Update Posted:
2017-01-16
First Post:
2006-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The AURA 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:
None
Brief Summary:
The aim of the study is to investigate the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will last up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast.
For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).
For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).
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?: