Symptom Clusters and Immune Markers in Patients With Chronic Obstructive Pulmonary Disease (COPD) - a Longitudinal Study (SGIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01016587
Recruitment Status : Completed
First Posted : November 19, 2009
Last Update Posted : February 11, 2014
University of California, San Francisco
Information provided by (Responsible Party):
Tone Rustøen, Oslo University Hospital

Brief Summary:

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

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:

  1. 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.
  2. Identify the occurrence of HGG and assess immune function in COPD patients.
  3. 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
Observational Model: Cohort
Time Perspective: Prospective
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

COPD patients
Not hospitalized COPD patients, degree 2-4.

Primary Outcome Measures :
  1. symptom clusters in patients with COPD [ Time Frame: 5 times during 12 months ]

Secondary Outcome Measures :
  1. 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
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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01016587

Oslo University Hospital
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
University of California, San Francisco

Responsible Party: Tone Rustøen, Senior Researcher, Oslo University Hospital Identifier: NCT01016587     History of Changes
Other Study ID Numbers: 2009055
First Posted: November 19, 2009    Key Record Dates
Last Update Posted: February 11, 2014
Last Verified: February 2014

Keywords provided by Tone Rustøen, Oslo University Hospital:
genetic markers
immune markers
Quality of Life

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Pathologic Processes