Evaluation of Biomarkers of COPD Exacerbation

SAA Level and SAA/Lipoxin A4 Ratio Clinical Trial

Official title:

Evaluation of Biomarkers of COPD Exacerbation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03609541
• Other study ID #: Protocol DG2.0-08.05.2018
• Status: Recruiting
• Start date: July 1, 2018
• Est. completion date: June 2023

Study information

• Verified date: July 2022
• Source: Heidelberg University
• Contact: Daniela Gompelmann, MD
• Phone: 004962213968087
• Email: daniela.gompelmann[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• SAA Level and SAA/Lipoxin A4 Ratio

Locations

Country	Name	City	State
Germany	Thoraxklinik Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SAA	SAA level in stable COPD and COPD exacerbation	time of exacerbation/hospitalisation, an average of 3 days
Primary	SAA/lipoxin A4 ratio	SAA/lipoxin A4 ratio in stable COPD and COPD exacerbation	time of exacerbation/hospitalisation, an average of 3 days