Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04023409 |
| Other study ID # |
NL46286.042.14 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 18, 2014 |
| Est. completion date |
July 10, 2019 |
Study information
| Verified date |
June 2024 |
| Source |
University Medical Center Groningen |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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.
