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Clinical Trials/NCT03609541
NCT03609541UnknownNot Applicable

Evaluation of Biomarkers of COPD Exacerbation

Heidelberg University1 site in 1 country80 target enrollmentStarted: July 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Daniela Gompelmann

PD Dr. med. Daniela Gompelmann

Heidelberg University

Study Sites (1)

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