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 parameters,…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 similar characteristics. These phenotypes are potentially based on a
combination of lung function parameters, clinical parameters, radiologic
parameters, and systemic parameters and genotypes and endotypes, in patients
with severe COPD.
Secondary outcome
NA
Background summary
In patients with Chronic Obstructive Pulmonary Disease (COPD), the degree of
airflow limitation itself does not adequately describe the complexity of COPD
because significant heterogeneity exists between patients with respect to
clinical presentation, physiology, imaging, response to therapy, decline in
lung function and survival. Currently, a clear alternative for describing COPD
does not exists but the identification of subgroups of COPD patients based on
clinical or genetic factors (phenotypes) could be useful. The continuous flow
of very severe COPD patients to the UMCG gives us the unique opportunity to
perform a study on the phenotypes of very severe COPD and the underlying
gene-environment interaction. We 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.
Study objective
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 parameters,
clinical parameters, radiologic parameters, systemic parameters, pathological
parameters and immunological parameters) in patients with severe COPD.
- identify endotypes/ intermediate phenotypes in patients with severe COPD.
- investigate the contribution of genotypes (including gene expression) in
patients with severe COPD.
Study design
Observational cross-sectional study with a 2 phase design
Study burden and risks
This low risk study does not have individual benefits for the participating
patients. Furthermore, the study will only take in total ± 2 extra hours and
will be performed during regular visits. Hopefully, the identification of novel
phenotypes will be useful for obtaining a more complete and realistic diagnosis
and a more tailored approach in the management of patients with severe COPD.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
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)
• Written informed consent.
Exclusion criteria
There are no exclusion criteria for this study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL46286.042.14 |