Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-02-18 @ 2:11 PM
Study NCT ID:
NCT02346292
Status:
COMPLETED
Last Update Posted:
2017-12-22
First Post:
2015-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Multicenter Non-interventional Study on COPD Patients Treatment Strategies at the Time of Hospital Discharge and Within 12 Months of Follow-up on an Outpatient Primary Care Basement
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
Observational Multicenter Non-interventional Study on COPD Patients Treatment Strategies at the Time of Hospital Discharge and Within 12 Months of Follow-up on an Outpatient Primary Care Basement
Status:
COMPLETED
Status Verified Date:
2017-12
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:
CLOUD
Brief Summary:
The study is an observational multicenter descriptive study. It is planned to enroll approximately 1250 subjects with severe and very severe COPD hospitalized for the reason of COPD exacerbation into departments of pulmonology or therapy. The study will be conducted in approximately 20-25 institutions of treatment and prevention in Russian Federation and will include about 50 to 60 subject at each clinical site.
Detailed Description:
The study is an observational multicenter descriptive study. It is planned to enroll approximately 1000 subjects with severe and very severe COPD hospitalized for the reason of COPD exacerbation into departments of pulmonology or therapy. The study will be conducted in approximately 20-25 institutions of treatment and prevention in Russian Federation and will include about 50 to 60 subject at each clinical site.
This is an observational study, so there is no treatment protocol or subjects' management recommendations required. The study subjects receive medical treatment according to the routine practice for their disease in Russian Federation. A subject's participation in this clinical study should not affect character and amount of care provided according to the routine clinical practice.
The study includes 5 clinical visits: Study Enrolment Visit, Month 3 Visit, Month 6 visit, Month 9 Visit, Month 12 visit / End of Study Visit.
This is an observational study, so there is no treatment protocol or subjects' management recommendations required. The study subjects receive medical treatment according to the routine practice for their disease in Russian Federation. A subject's participation in this clinical study should not affect character and amount of care provided according to the routine clinical practice.
The study includes 5 clinical visits: Study Enrolment Visit, Month 3 Visit, Month 6 visit, Month 9 Visit, Month 12 visit / End of Study Visit.
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?: