Symptom Clusters and Immune Markers in Patients With Chronic Obstructive Pulmonary Disease (COPD) - a Longitudinal Study (SGIS)
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Purpose
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 |
|---|
|
Chronic Obstructive Pulmonary Disease |
| Study Type: | Observational |
| 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.
| Estimated Enrollment: | 308 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
COPD patients
Not hospitalized COPD patients, degree 2-4.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
308 COPD patients
Inclusion Criteria:
- degree 2-4
- above 18 years of age
- able to read/ write/ speak Norwegian
Exclusion Criteria:
- patients who are receiving treatment for cancer
- acute exacerbations of COPD
Contacts and Locations| Contact: Tone Rustøen, Professor | +4723225462 | tone.rustoen@rr-research.no |
| Contact: Are Holm, PhD | +47237029 | are.holm@medisin.uio.no |
| Norway | |
| Oslo University Hospital | Recruiting |
| Oslo, Norway | |
| Contact: Tone Rustøen, Professor +4722119530 tone.rustoen@rr-research.no | |
| Contact: Are Holm, PhD +472372029 are.holm@medisin.uio.no | |
| Principal Investigator: Tone Rustøen, Professor | |
| Sub-Investigator: Are Holm, PhD | |
More Information
No publications provided
| Responsible Party: | Tone Rustøen, Senior Researcher, Oslo University Hospital |
| ClinicalTrials.gov Identifier: | NCT01016587 History of Changes |
| Other Study ID Numbers: | 2009055 |
| Study First Received: | November 18, 2009 |
| Last Updated: | October 29, 2012 |
| Health Authority: | Norway: Data Protection Authority Norway:National Committee for Medical and Health Research Ethics |
Keywords provided by Oslo University Hospital:
|
symptoms dyspnea pain fatigue anxiety depression |
sleeplessness genetic markers immune markers Symptoms COPD Quality of Life |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Syndrome |
Lung Diseases, Obstructive Respiratory Tract Diseases Disease Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013