Evaluation of Biomarkers of COPD Exacerbation
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Heidelberg University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- SAA/lipoxin A4 ratio
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
SAA/lipoxin A4 ratio
Time Frame: time of exacerbation/hospitalisation, an average of 3 days
SAA/lipoxin A4 ratio in stable COPD and COPD exacerbation
SAA
Time Frame: time of exacerbation/hospitalisation, an average of 3 days
SAA level in stable COPD and COPD exacerbation
Secondary Outcomes
No secondary outcomes reported
Investigators
Daniela Gompelmann
PD Dr. med. Daniela Gompelmann
Heidelberg University