NCT05504993

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2022

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

August 14, 2022

Last Update Submit

August 16, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Frequency of AECOPD

    Frequency of AECOPD in the last one year

    1 year

Secondary Outcomes (2)

  • Having at least one severe AECOPD

    1 year

  • Frequency of AECOPD for the next one year

    1 year

Study Arms (2)

High comorbidity group

CCI equal or higher than 2 COTE equal or higher than 4 COMCOLD equal or higher than 4

Other: Frequency of AECOPD

Low comorbidity group

CCI lower than 2 COTE lower than 4 COMCOLD lower than 4

Other: Frequency of AECOPD

Interventions

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

High comorbidity groupLow comorbidity group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • COPD patients
  • Admitted to the ward for AECOPD

You may not qualify if:

  • Not giving informed consent
  • Unable to perform PFT
  • Lost to follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Faculty of Medicine

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University Lecturer

Study Record Dates

First Submitted

August 14, 2022

First Posted

August 17, 2022

Study Start

January 1, 2018

Primary Completion

July 1, 2018

Study Completion

January 1, 2022

Last Updated

August 17, 2022

Record last verified: 2022-08

Locations