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

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT01016587
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-18
• Study First Submitted QC: 2009-11-18
• Study First Posted: 2009-11-19
• Primary Completion: 2013-10
• Status Verified: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-10
• Last Update Posted: 2014-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 275

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
symptom clusters in patients with COPD	5 times during 12 months

Secondary Outcome Measures

Name	Time	Method
Evaluate potential candidate genes in relation to symptom clusters and investigate the relationship between hypogammaglobulinemia and symptoms in COPD.	2 times during 12 months

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway