Viewing Study NCT03577795


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Study NCT ID: NCT03577795
Status: COMPLETED
Last Update Posted: 2022-02-10
First Post: 2018-05-23
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: A Prospective Cohort Study of Asthma and COPD Overlap in Japanese COPD Patients Using the Diagnostic Criteria of The Japanese Respiratory Society
Sponsor: AstraZeneca
Organization:

Study Overview

Official Title: A Prospective Cohort Study of Asthma and COPD Overlap in Japanese COPD Patients Using the Diagnostic Criteria of The Japanese Respiratory Society
Status: COMPLETED
Status Verified Date: 2022-01
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: ACO-Registry
Brief Summary: This study is a multicentered and non-interventional prospective cohort study. Study centers shall be the institutions where the examinations, adopted in the ACO diagnostic criteria9) from The Japanese Respiratory Society, are performed at least once a year as a part of their regular practice. Physicians participating in the study will consecutively register by means of central registration outpatients who have the characteristics of COPD in the ACO diagnostic criteria9) from The Japanese Respiratory Society, and who have been confirmed to satisfy the inclusion criteria whereas not violating the exclusion criteria.
Detailed Description: This study is a multicentered and non-interventional prospective cohort study. Study centers shall be the institutions where the examinations, adopted in the ACO diagnostic criteria9) from The Japanese Respiratory Society, are performed at least once a year as a part of their regular practice. Physicians participating in the study will consecutively register by means of central registration outpatients who have the characteristics of COPD in the ACO diagnostic criteria9) from The Japanese Respiratory Society, and who have been confirmed to satisfy the inclusion criteria whereas not violating the exclusion criteria. The physicians will collect data including the patients' results from medical examinations by using the ACO diagnostic criteria, at each time point (on the registration, after 1 year, and after 2 years). Electronic case report forms completed by participating physicians and questionnaires completed by patients will be used to collect data.

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: