The Identification of Phenotypes in Patients With Severe Chronic Obstructive Pulmonary Disease (Groningen Severe COPD Cohort)

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.

Study Overview

• Status: Completed
• Conditions: Severe COPD
• Intervention / Treatment: Other: NA: no intervention

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 Type: Observational
• Enrollment (Actual): 1030

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Severe COPD patients; Patients with severe COPD who are referred to the UMCG for a consultation on lung transplantation or bronchoscopic lung volume reduction.	Other: NA: no intervention; NA: no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical phenotypes	To identify new clinical phenotypes in patients with severe chronic obstructive pulmonary disease (COPD) using a cluster analysis.	baseline

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: Dirk-Jan Slebos, MD PhD, UMCG

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2014
• Primary Completion (Actual): July 10, 2019
• Study Completion (Actual): July 10, 2019

Study Registration Dates

• First Submitted: July 15, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (Actual): July 17, 2019

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: NL46286.042.14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Only on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No