Chronic Obstructive Pulmonary DiseaseNCT02076061
Biomarkers of Early Chronic Obstructive Pulmonary Disease (COPD) in Smokers - Longitudinal Study
An observational study of Chronic Obstructive Pulmonary Disease and Cardiovascular Disease, run by Lund University at 1 site in Sweden.
Trial summary
This is a longitudinal observational study to identify and validate protein biomarkers for COPD (chronic obstructive pulmonary diseases) and cardiovascular disease in smokers and ex-smokers attending primary care. Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Cardiovascular Disease, Lung Cancer
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2014to 30 Apr 2020
- 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 35 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinic in Malmö, Sweden
Who may be able to join
- Diagnosed with COPD Gold stage 0-IV
Who cannot join
- Patients with inflammatory diseases Patients with cancer Patients using immune system regulating drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomarkers of Early Chronic Obstructive Pulmonary Disease (COPD) and Cardiovascular Diseases in Smokers/Ex-Smokers Attending Primary Care - Longitudinal Study
This is a longitudinal observational study to identify and validate protein biomarkers for COPD (chronic obstructive pulmonary diseases) and cardiovascular disease in smokers and ex-smokers attending primary care. Special emphasize is to correlate biomarkers to different phases of COPD, to progression of the disease, and to treatment of the disease. Furthermore, linkage between COPD, cardiovascular disease, and lung cancer will be investigated by identifying protein biomarkers.
- Keywords
- COPD, Primary Care, Smoking, Smokers, ex-Smokers, Lung Cancer, Cardiovascular Disease, Proteomics, Biomarkers, Biobank, Disease Staging, Gold Stage
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cardiovascular Diseases, Lung Neoplasms, Smoking, Smoking Cessation
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 |
|---|---|---|
| GOLD stage I | Not described | |
| GOLD Stage II | Not described | |
| GOLD Stage III | Not described | |
| GOLD Stage IV | Not described | |
| Smokers/ex-smokers w/o COPD | Not described | |
| non-Smokers w/o COPD | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Advanced disease etiology requiring hospitalization.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Örestadskliniken
- Responsible party
- Principal investigator, Johan Malm, Lund University
- Investigators
- Johan Malm, Study chair, Clincal Chemistry, Lund UniversityGyörgy Marko-Varga, Principal investigator, Clinical Protein Science & Imaging, Lund UniversityMikael Truedsson, Principal investigator, Örestadskliniken MalmöElisabet Wieslander, Principal investigator, Division of Oncology and Pathology, Lund UniversityThomas E Fehniger, Principal investigator, Clinical Protein Science & Imaging, Lund UniversityMagnus Dahlbäck, Principal investigator, Clinical Protein Science & Imaging, Lund UniversityRoger Appelqvist, Principal investigator, Clinical Protein Science & Imaging, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076061
- Sponsor's protocol ID
- KOL 001
- Status last verified
- Aug 2022
- First submitted
- 27 Feb 2014
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Early Chronic Obstructive Pulmonary Disease (COPD) and Cardiovascular Diseases in Smokers/Ex-Smokers Attending Primary Care - Longitudinal Study
- ClinicalTrials.gov ID
- NCT02076061
- Acronym / sponsor ID
- KOL 001
- Keywords
- COPD, Primary Care, Smoking, Smokers, ex-Smokers, Lung Cancer, Cardiovascular Disease, Proteomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Örestadskliniken
- Study start
- Feb 2014
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 3 Mar 2014 (estimated)
- 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.
This is a longitudinal observational study to identify and validate protein biomarkers for COPD (chronic obstructive pulmonary diseases) and cardiovascular disease in smokers and ex-smokers attending primary care. Special emphasize is to correlate biomarkers to different phases of COPD, to progression of the disease, and to treatment of the disease. Furthermore, linkage between COPD, cardiovascular disease, and lung cancer will be investigated by identifying protein biomarkers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| GOLD stage I | – | – |
| GOLD Stage II | – | – |
| GOLD Stage III | – | – |
| GOLD Stage IV | – | – |
| Smokers/ex-smokers w/o COPD | – | – |
| non-Smokers w/o COPD | – | – |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic in Malmö, Sweden
Key inclusion criteria (1 listed)
- Diagnosed with COPD Gold stage 0-IV
Key exclusion criteria (1 listed)
- Patients with inflammatory diseases Patients with cancer Patients using immune system regulating drugs
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
Advanced disease etiology requiring hospitalization.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
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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.
Johan Malm study chair
Clincal Chemistry, Lund University
György Marko-Varga principal investigator
Clinical Protein Science & Imaging, Lund University
Mikael Truedsson principal investigator
Örestadskliniken Malmö
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 Chronic Obstructive Pulmonary Disease and Cardiovascular Disease, run by Lund University at 1 site in Sweden.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Aug 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Advanced disease etiology requiring hospitalization. (time frame: 2 years). 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 24 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.