CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,030 enrolled
Drug / intervention
NA: no interventionother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT04023409
NCT04023409N/ACompleted

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

University Medical Center Groningen·observational·Posted Jul 17, 2019·Updated Jun 18, 2024

In Brief

An observational study evaluating NA: no intervention for Severe COPD. Completed, enrolled 1,030 participants.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsSevere COPD
Countries--
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 17, 2019
Enrollment StartAug 18, 2014
Primary CompletionJul 10, 2019
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 7.0 years ago

Interventions

NA: no interventionother

NA: no intervention