Biomarkers of Early Chronic Obstructive Pulmonary Disease (COPD) in Smokers - Longitudinal Study

Sponsor

Lund University (Other)

Overall Status

Completed

CT.gov ID

NCT02076061

Collaborator

Örestadskliniken (Other)

300

Enrollment

Location

74.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a longitudinal observational study to identify and validate protein biomarkers for COPD (chronic obstructive pulmonary diseases) and cardiovascular disease in smokers and ex-smokers attending primary care. Special emphasize is to correlate biomarkers to different phases of COPD, to progression of the disease, and to treatment of the disease. Furthermore, linkage between COPD, cardiovascular disease, and lung cancer will be investigated by identifying protein biomarkers.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease Cardiovascular Disease Lung Cancer

Study Design

Study Type:

Observational

Actual Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Biomarkers of Early Chronic Obstructive Pulmonary Disease (COPD) and Cardiovascular Diseases in Smokers/Ex-Smokers Attending Primary Care - Longitudinal Study

Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Apr 30, 2020

Actual Study Completion Date :

Apr 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
GOLD stage I
GOLD Stage II
GOLD Stage III
GOLD Stage IV
Smokers/ex-smokers w/o COPD
non-Smokers w/o COPD

Outcome Measures

Primary Outcome Measures

Advanced disease etiology requiring hospitalization. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Diagnosed with COPD Gold stage 0-IV

Exclusion Criteria:

Patients with inflammatory diseases Patients with cancer Patients using immune system regulating drugs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Örestadskliniken	Malmö		Sweden

Sponsors and Collaborators

Lund University
Örestadskliniken

Investigators

Study Chair: Johan Malm, Clincal Chemistry, Lund University
Principal Investigator: György Marko-Varga, Clinical Protein Science & Imaging, Lund University
Principal Investigator: Mikael Truedsson, Örestadskliniken Malmö
Principal Investigator: Elisabet Wieslander, Division of Oncology and Pathology, Lund University
Principal Investigator: Thomas E Fehniger, Clinical Protein Science & Imaging, Lund University
Principal Investigator: Magnus Dahlbäck, Clinical Protein Science & Imaging, Lund University
Principal Investigator: Roger Appelqvist, Clinical Protein Science & Imaging, Lund University