Evaluation of Biomarkers of COPD Exacerbation

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.

Study Overview

• Status: Recruiting
• Conditions: SAA Level and SAA/Lipoxin A4 Ratio

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 Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Daniela Gompelmann, MD; Phone Number: 004962213968087; Email: daniela.gompelmann@med.uni-heidelberg.de

Study Locations

• Germany
  • Heidelberg, Germany, 69126
    • Recruiting
    • Thoraxklinik Heidelberg
    • Contact: Daniela Gompelmann, MD; Phone Number: +49(0)62213968087; Email: daniela.gompelmann@thoraxklinik-heidelberg.de
    • Principal Investigator: Daniela Gompelmann, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with COPD GOLD 3-4 confirmed by anamnesis and pulmonary function test (stable COPD and COPD exacerbation)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patient with stable COPD; Evaluation of serum amlyoid A, lipoxin A4, CRP and fibrinogen
Patient with COPD exacerbation; Evaluation of serum amlyoid A, lipoxin A4, CRP and Fibrinogen at beginning and at the end of COPD exacerbation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SAA	SAA level in stable COPD and COPD exacerbation	time of exacerbation/hospitalisation, an average of 3 days
SAA/lipoxin A4 ratio	SAA/lipoxin A4 ratio in stable COPD and COPD exacerbation	time of exacerbation/hospitalisation, an average of 3 days

Collaborators and Investigators

• Sponsor: Heidelberg University
• Investigators: Principal Investigator: Daniela Gompelmann, MD, Thoraxklinik University of Heidelberg

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: July 24, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 4, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Protocol DG2.0-08.05.2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No