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

This study has been completed.
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Tone Rustøen, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01016587
First received: November 18, 2009
Last updated: February 10, 2014
Last verified: February 2014
  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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • symptom clusters in patients with COPD [ Time Frame: 5 times during 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Enrollment: 275
Study Start Date: November 2009
Study Completion Date: February 2014
Primary Completion Date: October 2013 (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:

  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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

308 COPD patients

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01016587

Locations
Norway
Oslo University Hospital
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
University of California, San Francisco
  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: February 10, 2014
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
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Syndrome
Disease
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 22, 2014