Symptom Clusters and Immune Markers in Patients With Chro... | NCT01016587

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

NCT01016587

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Feb 11, 2014Estimated

Enrollment

275Actual

Phase

Not provided

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Not provided

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Oct 2013Actual

Completion Date

Feb 2014Actual

First Submitted Date

Nov 18, 2009

First Submission Date that Met QC Criteria

Nov 18, 2009

First Posted Date

Nov 19, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2014

Last Update Posted Date

Feb 11, 2014Estimated

Name	Class
University of California, San Francisco	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.
Identify the occurrence of HGG and assess immune function in COPD patients.
Explore relationships between HGG and immune function, genetic markers, symptoms, symptom clusters, health and respiratory status, frequency of exacerbations and health-related QOL.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

275Actual

Label	Type	Description	Intervention Names
COPD patients		Not hospitalized COPD patients, degree 2-4.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
symptom clusters in patients with COPD		5 times during 12 months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

308 COPD patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital		Oslo			Norway

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D004417	Dyspnea
D010146	Pain
D005221	Fatigue
D001008	Anxiety Disorders
D003863	Depression
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided

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.