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

Chronic Obstructive Pulmonary Disease Clinical Trial

— SGIS  

Official title:

Symptom Clusters and Immune Markers in Patients With COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01016587
• Other study ID #: 2009055
• Status: Completed
• Phase: N/A
• First received: November 18, 2009
• Last updated: February 10, 2014
• Start date: November 2009
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Data Protection AuthorityNorway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: February 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Syndrome

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	University of California, San Francisco

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptom clusters in patients with COPD		5 times during 12 months	No
Secondary	Evaluate potential candidate genes in relation to symptom clusters and investigate the relationship between hypogammaglobulinemia and symptoms in COPD.		2 times during 12 months	No