Symptom Clusters and Immune Markers in Patients With Chronic Obstructive Pulmonary Disease (COPD) - a Longitudinal Study (SGIS)
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|ClinicalTrials.gov Identifier: NCT01016587|
Recruitment Status : Completed
First Posted : November 19, 2009
Last Update Posted : February 11, 2014
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.
|Condition or disease|
|Chronic Obstructive Pulmonary Disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||275 participants|
|Official Title:||Symptom Clusters and Immune Markers in Patients With COPD|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||February 2014|
Not hospitalized COPD patients, degree 2-4.
- symptom clusters in patients with COPD [ Time Frame: 5 times during 12 months ]
- 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 ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01016587
|Oslo University Hospital|