SAA Level and SAA/Lipoxin A4 RatioNCT03609541
Evaluation of Biomarkers of COPD Exacerbation
An observational study of SAA Level and SAA/Lipoxin A4 Ratio, run by Heidelberg University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SAA Level and SAA/Lipoxin A4 Ratio
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2018to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with COPD GOLD 3-4 confirmed by anamnesis and pulmonary function test (stable COPD and COPD exacerbation)
Who may be able to join
- Patients with COPD GOLD 3-4 confirmed by anamnesis and pulmonary function test
- Patient has provided written informed consent
Who cannot join
- other reasons for worsening of symptoms (cough, dyspnea): e.g. pneumothorax, pneumonia, pulmonary embolism, myocardial infarction.
- malignant disease
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Thoraxklinik Heidelberg
Heidelberg, 69126
Daniela Gompelmann, MD, +49(0)62213968087, daniela.gompelmann@thoraxklinik-heidelberg.de
Daniela Gompelmann, MD
About this study
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.
Read the 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.
- Conditions
- SAA Level and SAA/Lipoxin A4 Ratio
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
SAA
SAA level in stable COPD and COPD exacerbation
Measured: time of exacerbation/hospitalisation, an average of 3 days
SAA/lipoxin A4 ratio
SAA/lipoxin A4 ratio in stable COPD and COPD exacerbation
Measured: time of exacerbation/hospitalisation, an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Jul 2018
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SAA Level and SAA/Lipoxin A4 RatioStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Gompelmann, Heidelberg University
- Investigators
- Daniela Gompelmann, MD, Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609541
- Sponsor's protocol ID
- Protocol DG2.0-08.05.2018
- Status last verified
- Jul 2022
- First submitted
- 16 Jul 2018
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Biomarkers of COPD Exacerbation
- ClinicalTrials.gov ID
- NCT03609541
- Acronym / sponsor ID
- Protocol DG2.0-08.05.2018
- Conditions
- SAA Level and SAA/Lipoxin A4 Ratio
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COPD GOLD 3-4 confirmed by anamnesis and pulmonary function test (stable COPD and COPD exacerbation)
Key inclusion criteria (2 listed)
- Patients with COPD GOLD 3-4 confirmed by anamnesis and pulmonary function test
- Patient has provided written informed consent
Key exclusion criteria (2 listed)
- other reasons for worsening of symptoms (cough, dyspnea): e.g. pneumothorax, pneumonia, pulmonary embolism, myocardial infarction.
- malignant disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SAA
Time frame: time of exacerbation/hospitalisation, an average of 3 days
SAA level in stable COPD and COPD exacerbation
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela Gompelmann, MD principal investigator
Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SAA Level and SAA/Lipoxin A4 Ratio, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniela Gompelmann, MD (004962213968087, daniela.gompelmann@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAA (time frame: time of exacerbation/hospitalisation, an average of 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.