Chronic Obstructive Lung DiseaseNCT05504993
Are Comorbidities Related to Frequent Severe Exacerbations of AECOPD
An observational study of Chronic Obstructive Lung Disease and Acute Exacerbation of COPD, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Lung Disease, Acute Exacerbation of COPD, Comorbidities and Coexisting Conditions
- What is being tested?
- Frequency of AECOPD
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- COPD patients
- Admitted to the ward for AECOPD
Who cannot join
- Not giving informed consent
- Unable to perform PFT
- Lost to follow-up
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Chronic Obstructive Lung Disease, Acute Exacerbation of COPD, Comorbidities and Coexisting Conditions
- Being tested
- Frequency of AECOPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frequency of AECOPDOther
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
| Study group | Role | What they receive |
|---|---|---|
| High comorbidity group | CCI equal or higher than 2 COTE equal or higher than 4 COMCOLD equal or higher than 4 Receives: Other: Frequency of AECOPD | |
| Low comorbidity group | CCI lower than 2 COTE lower than 4 COMCOLD lower than 4 Receives: Other: Frequency of AECOPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of AECOPD
Frequency of AECOPD in the last one year
Measured: 1 year
Secondary outcomes (2)
Having at least one severe AECOPD
having at least one severe AECOPD in the last year
Measured: 1 year
Frequency of AECOPD for the next one year
the number of AECOPD for 1 year period from the preceding admission, regardless of severity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start1 Jan 2018
- Primary completion1 Jul 2018
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Doğan Mülazimoğlu, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504993
- Sponsor's protocol ID
- 05-305-18
- Status last verified
- Aug 2022
- First submitted
- 14 Aug 2022
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Comorbidities Related to Frequent Severe Exacerbations of AECOPD
- ClinicalTrials.gov ID
- NCT05504993
- Acronym / sponsor ID
- 05-305-18
- Conditions
- Chronic Obstructive Lung Disease, Acute Exacerbation of COPD, Comorbidities and Coexisting Conditions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High comorbidity group | – | Other: Frequency of AECOPDCCI equal or higher than 2 COTE equal or higher than 4 COMCOLD equal or higher than 4 |
| Low comorbidity group | – | Other: Frequency of AECOPDCCI lower than 2 COTE lower than 4 COMCOLD lower than 4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- COPD patients
- Admitted to the ward for AECOPD
Key exclusion criteria (3 listed)
- Not giving informed consent
- Unable to perform PFT
- Lost to follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frequency of AECOPDNo 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 | Other | High comorbidity group, Low comorbidity group |
Primary outcome
Frequency of AECOPD
Time frame: 1 year
Frequency of AECOPD in the last one year
2 secondary outcomes
Having at least one severe AECOPD
Time frame: 1 year
Frequency of AECOPD for the next one year
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Lung Disease and Acute Exacerbation of COPD, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of AECOPD (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.