Symptom Clusters and Immune Markers in Patients With Chronic Obstructive Pulmonary Disease (COPD) - a Longitudinal Study (SGIS)
COPD patients often have a wide range of physical (e.g., dyspnea, fatigue, pain) and psychological (e.g., depression, anxiety) symptoms and various other debilitating conditions that cause considerable suffering for the individual. Unfortunately, many of the symptoms and health problems in patients with COPD are unrecognized and untreated. Due to the irreversible nature of COPD, the aim is not to cure the disease, but to reduce symptoms and improve quality of life.
Therefore, the purpose of this project is to investigate the existence and nature of symptom clusters over time in patients with COPD and their effects on patient outcomes. Since this study aims to identify possible new subgroups of patients with COPD defined by the clustering of certain symptoms, the study also aims to investigate the relationship between the clinical presentation and certain immunologic and genetic factors.
Chronic Obstructive Pulmonary Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Symptom Clusters and Immune Markers in Patients With COPD|
- symptom clusters in patients with COPD [ Time Frame: 5 times during 12 months ] [ Designated as safety issue: No ]
- Evaluate potential candidate genes in relation to symptom clusters and investigate the relationship between hypogammaglobulinemia and symptoms in COPD. [ Time Frame: 2 times during 12 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
One foci is to perform a genome wide association study in patient with COPD to identify novel genetic markers for the patient subgroups who report different experiences with the symptom cluster of pain, fatigue, breathlessness, sleep disturbance, and depression. It is likely that genetic and immunologic factors may be involved in symptom severity and morbidity. Specifically, low levels of circulating immunoglobulins have been observed in a subset of COPD patients. Although hypogammaglobulinemia (HGG) is known to lead to frequent airway infections in other patients groups, the relationship between HGG and clinical symptoms in COPD has not been studied. The resulting knowledge can help clinicians to better identify COPD patients at particular risk for severe single and multiple symptoms.
|Study Start Date:||November 2009|
|Study Completion Date:||February 2014|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Not hospitalized COPD patients, degree 2-4.
The specific aims of this translational, interdisciplinary, multi-center, international research study will follow 308 COPD patients with repeated measures over 12 months, are to:
- Explore COPD patients' symptoms, symptom clusters, and changes in symptoms and symptom clusters over time; as well as the genetic markers for subgroups of patients with different symptom clusters.
- Identify the occurrence of HGG and assess immune function in COPD patients.
- Explore relationships between HGG and immune function, genetic markers, symptoms, symptom clusters, health and respiratory status, frequency of exacerbations and health-related QOL.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016587
|Oslo University Hospital|