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

NCT01016587 | Completed DMC

• 1 other identifier: 2009055
• Study Type: observational
• Target: 275
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

symptoms; dyspnea; pain; fatigue; anxiety; depression; sleeplessness; genetic markers; immune markers; COPD; Quality of Life

Outcome Measures

Primary Outcomes (1)

• symptom clusters in patients with COPD

  5 times during 12 months

Secondary Outcomes (1)

• Evaluate potential candidate genes in relation to symptom clusters and investigate the relationship between hypogammaglobulinemia and symptoms in COPD.

  2 times during 12 months

Study Arms (1)

COPD patients

Not hospitalized COPD patients, degree 2-4.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

308 COPD patients

You may qualify if:

• degree 2-4
• above 18 years of age
• able to read/ write/ speak Norwegian

You may not qualify if:

• patients who are receiving treatment for cancer
• acute exacerbations of COPD

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of California, San Francisco: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea; Pain; Fatigue; Anxiety Disorders; Depression; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Neurologic Manifestations; Mental Disorders; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: November 19, 2009
• Study Start: November 1, 2009
• Primary Completion: October 1, 2013
• Study Completion: February 1, 2014
• Last Updated: February 11, 2014

Record last verified: 2014-02

Locations

NO (1)