Evaluation of Biomarkers of COPD Exacerbation

NCT ID: NCT03609541

Last Updated: 2022-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2023-06-30

Brief Summary

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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

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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.

Conditions

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SAA Level and SAA/Lipoxin A4 Ratio

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient with stable COPD

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

No interventions assigned to this group

Patient with COPD exacerbation

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Daniela Gompelmann

PD Dr. med. Daniela Gompelmann

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniela Gompelmann, MD

Role: PRINCIPAL_INVESTIGATOR

Thoraxklinik University of Heidelberg

Locations

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Thoraxklinik Heidelberg

Heidelberg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Daniela Gompelmann, MD

Role: CONTACT

004962213968087

Facility Contacts

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Daniela Gompelmann, MD

Role: primary

+49(0)62213968087

Other Identifiers

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Protocol DG2.0-08.05.2018

Identifier Type: -

Identifier Source: org_study_id

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