Are Comorbidities Related to Frequent Severe Exacerbations of AECOPD

August 16, 2022 updated by: Deniz Doğan Mülazimoğlu, Ankara University

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

Study Type

Observational

Enrollment (Actual)

92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey
        • Ankara University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study included all patients, admitted to pulmonary diseases department, and hospitalized in ward for acute exacerbation of COPD (AECOPD) for a six-month period.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

August 14, 2022

First Submitted That Met QC Criteria

August 16, 2022

First Posted (Actual)

August 17, 2022

Study Record Updates

Last Update Posted (Actual)

August 17, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 05-305-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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