Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-09 @ 1:49 PM
Study NCT ID:
NCT02413359
Status:
COMPLETED
Last Update Posted:
2016-09-21
First Post:
2015-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Risk Populations Among COPD Patients in Japan
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
Research Study in Patients With COPD in High Risk Population in Japan: Proportion of Overlap Between COPD and Asthma, and the Relationship With COPD Exacerbation
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 patients with complications of COPD and asthma have features mixed with two diseases, COPD and asthma. Therefore, the outcomes are worsened if the patients with COPD have symptoms overlapped with asthma, however, no sufficient data exist in Japan for estimating the prevalence of ACOS in patients with COPD. The primary objective of this NIS is to clarify the proportion of ACOS defined by GINA and GOLD in patients with COPD. The main secondary objectives are To explore the features of history of COPD exacerbations, symptoms, eosinophilic inflammation and patient background in patients with ACOS, to clarify the history of COPD exacerbations in patients with COPD, to evaluate the degrees of eosinophilic inflammation of the respiratory tract in patients with COPD and to evaluate the symptoms in patients with COPD. This is a cross-sectional study targeting COPD patients receiving outpatient treatment and follow-up by physicians in Japan. FSI is scheduled as 2Q 2015 and DBL would be locked by 3Q 2015.
Detailed Description:
Study Site(s), number of subjects planned Number of study sites planned for this research study (scheduled) 60 (undetermined) Number of subjects planned for this research study (scheduled) 1,100 patients
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?: