Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-02-26 @ 12:41 AM
Study NCT ID:
NCT02068456
Status:
COMPLETED
Last Update Posted:
2017-06-22
First Post:
2014-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Marketing Surveillance of Roflumilast in Korea
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
Post Marketing Surveillance of Roflumilast in Korea
Status:
COMPLETED
Status Verified Date:
2017-06
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 purpose of this study is to evaluate the safety and efficacy of roflumilast in the real-use conditions with its registered indications.
Detailed Description:
The drug being tested in this study is called roflumilast. Roflumilast is used to treat people who have severe chronic obstructive pulmonary disease (COPD) forced expiratory volume in 1 second (FEV1) post-bronchodilator less than 50% predicted) associated with chronic bronchitis with a history of worsening symptoms. This study will look at side effects and the lung function of people who take roflumilast.
The study will enroll approximately 3000 patients who plan to take roflumilast as an add on to bronchiodilator treatment by their healthcare provider. This multi-centre trial will be conducted in Korea.. The administration period of the roflumilast is determined in accordance with actual treatment policy for the subject, Subjects will be evaluated during routine appointments with their healthcare provider.
This multi-centre trial will be conducted in Korea. The overall time to participate in this study is up to 1 month. Participants will be evaluated during routine appointments with their healthcare provider.
The study will enroll approximately 3000 patients who plan to take roflumilast as an add on to bronchiodilator treatment by their healthcare provider. This multi-centre trial will be conducted in Korea.. The administration period of the roflumilast is determined in accordance with actual treatment policy for the subject, Subjects will be evaluated during routine appointments with their healthcare provider.
This multi-centre trial will be conducted in Korea. The overall time to participate in this study is up to 1 month. Participants will be evaluated during routine appointments with their healthcare provider.
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?: