Evaluation of Biomarkers of COPD Exacerbation | NCT03609541

Studies
Evaluation of Biomarkers of COPD Exacerbation

NCT03609541

Sponsor

Heidelberg University

Status

Unknown status

Last Update Posted

Jul 6, 2022Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

SAA Level and SAA/Lipoxin A4 Ratio

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2018Actual

Primary Completion Date

Jun 2023Estimated

Completion Date

Jun 2023Estimated

First Submitted Date

Jul 16, 2018

First Submission Date that Met QC Criteria

Jul 24, 2018

First Posted Date

Aug 1, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2022

Last Update Posted Date

Jul 6, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Daniela Gompelmann, PD Dr. med. Daniela Gompelmann, Heidelberg UniversityPrincipal Investigator

Lead Sponsor

Heidelberg UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Daniela Gompelmann, MD	Contact	004962213968087		daniela.gompelmann@med.uni-heidelberg.de

Overall Officials

Name	Affiliation	Role
Daniela Gompelmann, MD	Heidelberg University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Thoraxklinik Heidelberg	Recruiting	Heidelberg		69126	Germany