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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

November 18, 2009
February 10, 2014
November 2009
October 2013   (final data collection date for primary outcome measure)
symptom clusters in patients with COPD [ Time Frame: 5 times during 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01016587 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Symptom Clusters and Immune Markers in Patients With Chronic Obstructive Pulmonary Disease (COPD) - a Longitudinal Study
Symptom Clusters and Immune Markers in Patients With COPD

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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.

Non-Probability Sample

308 COPD patients

Chronic Obstructive Pulmonary Disease
Not Provided
COPD patients
Not hospitalized COPD patients, degree 2-4.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
275
February 2014
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01016587
2009055
Yes
Tone Rustøen, Oslo University Hospital
Oslo University Hospital
University of California, San Francisco
Not Provided
Oslo University Hospital
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP