- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05504993
Are Comorbidities Related to Frequent Severe Exacerbations of AECOPD
INTRODUCTION: Relationship between comorbidities and COPD is two-sided. While the number of comorbidities increasing, the frequency of acute exacerbations of COPD (AECOPD) is increasing, too. Comorbidity indexes can be used for recognition of comorbidities while managing COPD patients. In the present study, it is aimed to compare comorbidity indexes such as Charlson Comorbidity Index, COMCOLD and COTE in the matter of exacerbation frequency.
METHOD: Subjects hospitalized for AECOPD, admitted to the study. Exacerbation severity, frequency, further exacerbations for a 1-year period in the follow-up period and CCI, COMCOLD and COTE scores were recorded. High and low comorbidity groups were compared for AECOPD frequency, severity, and further exacerbations.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey
- Ankara University Faculty of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- COPD patients
- Admitted to the ward for AECOPD
Exclusion Criteria:
- Not giving informed consent
- Unable to perform PFT
- Lost to follow-up
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
High comorbidity group
CCI equal or higher than 2 COTE equal or higher than 4 COMCOLD equal or higher than 4
|
No intervention has been applied.
92 COPD patients divided into 2 groups according to their comorbidity level.
Than these groups were compared for their AECOPD frequency
|
|
Low comorbidity group
CCI lower than 2 COTE lower than 4 COMCOLD lower than 4
|
No intervention has been applied.
92 COPD patients divided into 2 groups according to their comorbidity level.
Than these groups were compared for their AECOPD frequency
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of AECOPD
Time Frame: 1 year
|
Frequency of AECOPD in the last one year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Having at least one severe AECOPD
Time Frame: 1 year
|
having at least one severe AECOPD in the last year
|
1 year
|
|
Frequency of AECOPD for the next one year
Time Frame: 1 year
|
the number of AECOPD for 1 year period from the preceding admission, regardless of severity
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-305-18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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