Evaluation of Biomarkers of COPD Exacerbation

Heidelberg University

Status: Enrolling

Conditions: SAA Level and SAA/Lipoxin A4 Ratio

Study type: Observational

Funder types: Other

Identifiers

NCT03609541

Protocol DG2.0-08.05.2018

Details and patient eligibility

About

Serum amlyoid A (SAA) was shown to act as biomarker for exacerbation of chronic obstructive pulmonary disease (AE-COPD). It seems that SAA triggers chronic inflammation by binding to ALX/PFR2 receptor. In contrast, lipoxin A4 seems to inhibit the inflammatory processes by binding to ALX/PFR2 receptor. A small trial has already demonstrated an imbalance between SAA and lipoxin A4 during AE-COPD. This study evaluates SAA level and SAA/lipoxin A4 ratio in patients with stable COPD and AE-COPD.

Full description

Patient enrolment and data aquisition is to be carried out on a prospective basis. It is planned to enrol 40 patients with stable COPD and 40 patients with AE-COPD. All patients will undergo blood sampling inlcuding SAA and Lipoxin A4.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with COPD GOLD 3-4 confirmed by anamnesis and pulmonary function test
• Patient has provided written informed consent

Exclusion criteria

• other reasons for worsening of symptoms (cough, dyspnea): e.g. pneumothorax, pneumonia, pulmonary embolism, myocardial infarction.
• malignant disease

Trial design

80 participants in 2 patient groups

Patient with stable COPD

Description:

Evaluation of serum amlyoid A, lipoxin A4, CRP and fibrinogen

Patient with COPD exacerbation

Description:

Evaluation of serum amlyoid A, lipoxin A4, CRP and Fibrinogen at beginning and at the end of COPD exacerbation