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

NCT04023409 | Completed

• 1 other identifier: NL46286.042.14
• Study Type: observational
• Target: 1,030
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Severe COPD

Outcome Measures

Primary Outcomes (1)

• clinical phenotypes

  To identify new clinical phenotypes in patients with severe chronic obstructive pulmonary disease (COPD) using a cluster analysis.

  baseline

Study Arms (1)

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

Interventions

NA: no intervention OTHER

NA: no intervention

Severe COPD patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Related Publications (2)

• 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. 2025 Oct 19. doi: 10.1002/resp.70146. Online ahead of print.

  PMID: 41111194 DERIVED

• Boersma 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.

  PMID: 39488255 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dirk-Jan Slebos, MD PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 17, 2019
• Study Start: August 18, 2014
• Primary Completion: July 10, 2019
• Study Completion: July 10, 2019
• Last Updated: June 18, 2024

Record last verified: 2024-06