Clinical trial NCT04023409: The Identification of Phenotypes in Patients With Severe Chronic Obstructive Pulmonary Disease (Groningen Severe COPD Cohort)
Official title: The Identification of Phenotypes in Patients With Severe Chronic Obstructive Pulmonary Disease (Groningen Severe COPD Cohort)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe COPD
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 1030
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with severe COPD who are referred to the UMCG for a consultation on lung transplantation or bronchoscopic lung volume reduction.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

- There are no exclusion criteria for this study.

Primary outcomes:
measure: clinical phenotypes
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UMCG
name: Dirk-Jan Slebos, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: