Severe COPDNCT04023409
The Identification of Phenotypes in Patients With Severe Chronic Obstructive Pulmonary Disease (Groningen Severe COPD Cohort)
An observational study of Severe COPD, run by University Medical Center Groningen.
Trial summary
Rationale: Chronic Obstructive Pulmonary Disease (COPD) is defined by airway obstruction. However, the degree of airflow limitation does not adequately describe the complexity of COPD because significant heterogeneity exists between patients with respect to their clinical presentation, physiology, imaging, response to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severe COPD
- How many people
- 1,030 participants
- Where
- No sites listed yet
- Study dates
- 18 Aug 2014to 10 Jul 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with severe COPD who are referred to the UMCG for a consultation on lung transplantation or bronchoscopic lung volume reduction.
Who may be able to join
- Referral to the LVR intervention team or LTx team of the (UMCG).
- Chronic Obstructive Pulmonary Disease (COPD) according the Global initiative for Chronic Obstructive Lung Disease (GOLD) criteria (post bronchodilator FEV1/FVC < 0.7)[1]
- Written informed consent.
Who cannot join
- There are no exclusion criteria for this study.
About this study
Rationale: Chronic Obstructive Pulmonary Disease (COPD) is defined by airway obstruction. However, the degree of airflow limitation does not adequately describe the complexity of COPD because significant heterogeneity exists between patients with respect to their clinical presentation, physiology, imaging, response to therapy, decline in lung function and survival. Currently, a clear alternative for describing COPD does not exist but the identification of subgroups of COPD patients based on clinical or genomic and epigenomic factors (phenotypes) could be useful. The continuous flow of very severe COPD patients to the UMCG gives the investigators the unique opportunity to perform a study on the phenotypes of very severe COPD and the underlying gene-environment interaction. The investigators anticipate that the findings of this study will lead to an earlier identification of those subjects who are at risk to develop severe or very severe COPD. In addition, it will lead to a better clinical characterisation of established COPD, possibly enabling a more tailored treatment of different COPD subphenotypes.
Objectives:
Read more
Primary Objective:
To identify new clinical phenotypes in patients with severe chronic obstructive pulmonary disease (COPD) using a cluster analysis.
Secondary Objectives:
To:
- identify clinical phenotypes (based on e.g. lung function, clinical, radiologic, systemic, pathological and immunological parameters) in patients with severe COPD.
- identify endotypes/ intermediate phenotypes in patients with severe COPD.
- investigate the contribution of (epi)genomics (including genetics and gene expression) to characterize patients with subsets of severe COPD.
Study design: Observational cross-sectional study with a 2 phase design
Study population: Patients with severe COPD who are referred to the UMCG for a consultation on lung transplantation or bronchoscopic lung volume reduction.
Read the detailed description
Rationale: Chronic Obstructive Pulmonary Disease (COPD) is defined by airway obstruction. However, the degree of airflow limitation does not adequately describe the complexity of COPD because significant heterogeneity exists between patients with respect to their clinical presentation, physiology, imaging, response to therapy, decline in lung function and survival. Currently, a clear alternative for describing COPD does not exist but the identification of subgroups of COPD patients based on clinical or genomic and epigenomic factors (phenotypes) could be useful. The continuous flow of very severe COPD patients to the UMCG gives the investigators the unique opportunity to perform a study on the phenotypes of very severe COPD and the underlying gene-environment interaction. The investigators anticipate that the findings of this study will lead to an earlier identification of those subjects who are at risk to develop severe or very severe COPD. In addition, it will lead to a better clinical characterisation of established COPD, possibly enabling a more tailored treatment of different COPD subphenotypes.
Objectives:
Primary Objective:
To identify new clinical phenotypes in patients with severe chronic obstructive pulmonary disease (COPD) using a cluster analysis.
Secondary Objectives:
To:
- identify clinical phenotypes (based on e.g. lung function, clinical, radiologic, systemic, pathological and immunological parameters) in patients with severe COPD.
- identify endotypes/ intermediate phenotypes in patients with severe COPD.
- investigate the contribution of (epi)genomics (including genetics and gene expression) to characterize patients with subsets of severe COPD.
Study design: Observational cross-sectional study with a 2 phase design
Study population: Patients with severe COPD who are referred to the UMCG for a consultation on lung transplantation or bronchoscopic lung volume reduction.
Main study parameters: The main study parameter is the identification of new clinical phenotypes. The collected data will allow us to identify new phenotypes, clusters of patients with comparable characteristics. These phenotypes are potentially based on a combination of lung function, clinical, radiologic, systemic and genomic parameters and endotypes, in patients with severe COPD.
- Conditions
- Severe COPD
- Being tested
- NA: no intervention
- 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.
NA: no interventionOther
NA: no intervention
| Study group | Role | What they receive |
|---|---|---|
| Severe COPD patients | Patients with severe COPD who are referred to the UMCG for a consultation on lung transplantation or bronchoscopic lung volume reduction. Receives: Other: NA: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical phenotypes
To identify new clinical phenotypes in patients with severe chronic obstructive pulmonary disease (COPD) using a cluster analysis.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start18 Aug 2014
- Primary completion10 Jul 2019
- Study completion10 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Severe COPDStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,030 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dirk-Jan Slebos, University Medical Center Groningen
- Investigators
- Dirk-Jan Slebos, MD PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023409
- Sponsor's protocol ID
- NL46286.042.14
- Status last verified
- Jun 2024
- First submitted
- 15 Jul 2019
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Only on request
Publications
Kuks PJM, Hartman JE, Ter Haar EAMD, van Pelt LJ, Slebos DJ, van den Berge M, Pouwels SD. Identification of Clinically Distinct Clusters in Patients With Severe COPD Using Circulating Blood Cell Population Parameters. Respirology. 2026 Feb;31(2):141-151. doi: 10.1002/resp.70146. Epub 2025 Oct 19.
PubMed 41111194Vandervelde CM, Hartman JE, Klooster K, Janssens W, Everaerts S, Bouneb S, Weder W, Slebos DJ, Ceulemans LJ. Surgical lung volume reduction eligibility in an emphysema patient pool referred for endoscopic treatment. BMC Pulm Med. 2025 Oct 17;25(1):479. doi: 10.1186/s12890-025-03954-w.
PubMed 41107777Boersma R, Bakker JT, de Vries M, Raveling T, Slebos DJ, Wijkstra PJ, Hartman JE, Duiverman ML. Defining a phenotype of severe COPD patients who develop chronic hypercapnia. Respir Med. 2024 Nov-Dec;234:107850. doi: 10.1016/j.rmed.2024.107850. Epub 2024 Oct 31.
PubMed 39488255
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Identification of Phenotypes in Patients With Severe Chronic Obstructive Pulmonary Disease (Groningen Severe COPD Cohort)
- ClinicalTrials.gov ID
- NCT04023409
- Acronym / sponsor ID
- NL46286.042.14
- Conditions
- Severe COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,030 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 18 Aug 2014 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 17 Jul 2019 (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.
Rationale: Chronic Obstructive Pulmonary Disease (COPD) is defined by airway obstruction. However, the degree of airflow limitation does not adequately describe the complexity of COPD because significant heterogeneity exists between patients with respect to their clinical presentation, physiology, imaging, response to therapy, decline in lung function and survival. Currently, a clear alternative for describing COPD does not exist but the identification of subgroups of COPD patients based on clinical or genomic and epigenomic factors (phenotypes) could be useful. The continuous flow of very severe COPD patients to the UMCG gives the investigators the unique opportunity to perform a study on the phenotypes of very severe COPD and the underlying gene-environment interaction. The investigators anticipate that the findings of this study will lead to an earlier identification of those subjects who are at risk to develop severe or very severe COPD. In addition, it will lead to a better clinical characterisation of established COPD, possibly enabling a more tailored treatment of different COPD subphenotypes.
Objectives:
Primary Objective:
To identify new clinical phenotypes in patients with severe chronic obstructive pulmonary disease (COPD) using a cluster analysis.
Secondary Objectives:
To:
- identify clinical phenotypes (based on e.g. lung function, clinical, radiologic, systemic, pathological and immunological parameters) in patients with severe COPD.
- identify endotypes/ intermediate phenotypes in patients with severe COPD.
- investigate the contribution of (epi)genomics (including genetics and gene expression) to characterize patients with subsets of severe COPD.
Study design: Observational cross-sectional study with a 2 phase design
Study population: Patients with severe COPD who are referred to the UMCG for a consultation on lung transplantation or bronchoscopic lung volume reduction.
Detailed description
Rationale: Chronic Obstructive Pulmonary Disease (COPD) is defined by airway obstruction. However, the degree of airflow limitation does not adequately describe the complexity of COPD because significant heterogeneity exists between patients with respect to their clinical presentation, physiology, imaging, response to therapy, decline in lung function and survival. Currently, a clear alternative for describing COPD does not exist but the identification of subgroups of COPD patients based on clinical or genomic and epigenomic factors (phenotypes) could be useful. The continuous flow of very severe COPD patients to the UMCG gives the investigators the unique opportunity to perform a study on the phenotypes of very severe COPD and the underlying gene-environment interaction. The investigators anticipate that the findings of this study will lead to an earlier identification of those subjects who are at risk to develop severe or very severe COPD. In addition, it will lead to a better clinical characterisation of established COPD, possibly enabling a more tailored treatment of different COPD subphenotypes.
Objectives:
Primary Objective:
To identify new clinical phenotypes in patients with severe chronic obstructive pulmonary disease (COPD) using a cluster analysis.
Secondary Objectives:
To:
- identify clinical phenotypes (based on e.g. lung function, clinical, radiologic, systemic, pathological and immunological parameters) in patients with severe COPD.
- identify endotypes/ intermediate phenotypes in patients with severe COPD.
- investigate the contribution of (epi)genomics (including genetics and gene expression) to characterize patients with subsets of severe COPD.
Study design: Observational cross-sectional study with a 2 phase design
Study population: Patients with severe COPD who are referred to the UMCG for a consultation on lung transplantation or bronchoscopic lung volume reduction.
Main study parameters: The main study parameter is the identification of new clinical phenotypes. The collected data will allow us to identify new phenotypes, clusters of patients with comparable characteristics. These phenotypes are potentially based on a combination of lung function, clinical, radiologic, systemic and genomic parameters and endotypes, in patients with severe COPD.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe COPD patients | – | Other: NA: no interventionPatients with severe COPD who are referred to the UMCG for a consultation on lung transplantation or bronchoscopic lung volume reduction. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with severe COPD who are referred to the UMCG for a consultation on lung transplantation or bronchoscopic lung volume reduction.
Key inclusion criteria (3 listed)
- Referral to the LVR intervention team or LTx team of the (UMCG).
- Chronic Obstructive Pulmonary Disease (COPD) according the Global initiative for Chronic Obstructive Lung Disease (GOLD) criteria (post bronchodilator FEV1/FVC < 0.7)[1]
- Written informed consent.
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study.
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 |
|---|---|---|
| NA: no interventionNA: no intervention | Other | Severe COPD patients |
Primary outcome
clinical phenotypes
Time frame: baseline
To identify new clinical phenotypes in patients with severe chronic obstructive pulmonary disease (COPD) using a cluster analysis.
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 18 Jun 2024.
- Derived from this study: PubMed 41111194Kuks PJM, Hartman JE, Ter Haar EAMD, van Pelt LJ, Slebos DJ, van den Berge M, Pouwels SD. Identification of Clinically Distinct Clusters in Patients With Severe COPD Using Circulating Blood Cell Population Parameters. Respirology. 2026 Feb;31(2):141-151. doi: 10.1002/resp.70146. Epub 2025 Oct 19.
- Derived from this study: PubMed 41107777Vandervelde CM, Hartman JE, Klooster K, Janssens W, Everaerts S, Bouneb S, Weder W, Slebos DJ, Ceulemans LJ. Surgical lung volume reduction eligibility in an emphysema patient pool referred for endoscopic treatment. BMC Pulm Med. 2025 Oct 17;25(1):479. doi: 10.1186/s12890-025-03954-w.
- Derived from this study: PubMed 39488255Boersma R, Bakker JT, de Vries M, Raveling T, Slebos DJ, Wijkstra PJ, Hartman JE, Duiverman ML. Defining a phenotype of severe COPD patients who develop chronic hypercapnia. Respir Med. 2024 Nov-Dec;234:107850. doi: 10.1016/j.rmed.2024.107850. Epub 2024 Oct 31.
- Individual participant dataSharing planned: Undecided. Only on request
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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.
Dirk-Jan Slebos, MD PhD principal investigator
University Medical Center Groningen
Questions about this trial
What is this clinical trial studying?
An observational study of Severe COPD, run by University Medical Center Groningen.
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 3 inclusion and 1 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 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
clinical phenotypes (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04023409, which also lists 3 linked publications.
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 18 Jun 2024.