Chronic Obstructive Pulmonary DiseaseBIG3NCT01460264
An Open Prospective Longitudinal Pulmonary-cardiovascular Cohort Study
An observational study of Chronic Obstructive Pulmonary Disease and Cardiovascular Diseases, run by Region Skane at 1 site in Sweden.
Trial summary
This is an observational study aiming to identify and validate biomarkers (including imaging and clinical descriptors) for chronic obstructive pulmonary disease (COPD), cardiovascular disease (CVD) and lung cancer. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Cardiovascular Diseases, Lung Cancer
- How many people
- 10,000 participants
- Where
- 1 siteSweden
- Study dates
- 16 Oct 2013to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community sample,residents in Skåne county Sweden.
Who may be able to join
- 45-75 years
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: BIG3 - An Open Prospective Longitudinal Pulmonary-cardiovascular Cohort Study
This is an observational study aiming to identify and validate biomarkers (including imaging and clinical descriptors) for chronic obstructive pulmonary disease (COPD), cardiovascular disease (CVD) and lung cancer.
- Keywords
- Prospective Cohort Study, Respiratory Function Tests, Computed Tomography, Electrocardiography, Peripheral Arterial Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cardiovascular Diseases, Lung Neoplasms, Peripheral Arterial Disease
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 |
|---|---|---|
| exposed | current daily smokers 100 cigarettes or more during lifetime | |
| unexposed | current non-smokers |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study start16 Oct 2013
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louise Hagman Bennet, MD, PhD, Study chair, Skane University HospitalDavid Erlinge, MD, PhD, Principal investigator, Skane University HospitalClaes-Göran Löfdahl, MD, PhD, Principal investigator, Skane University HospitalMaria Planck, MD, PhD, Principal investigator, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460264
- Sponsor's protocol ID
- BIG3-Region_Skane
- Acronym
- BIG3
- Status last verified
- Aug 2025
- First submitted
- 25 Oct 2011
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Gerhardsson de Verdier M. The big three concept: a way to tackle the health care crisis? Proc Am Thorac Soc. 2008 Dec 1;5(8):800-5. doi: 10.1513/pats.200806-058TH.
PubMed 19017732
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIG3 - An Open Prospective Longitudinal Pulmonary-cardiovascular Cohort Study
- ClinicalTrials.gov ID
- NCT01460264
- Acronym / sponsor ID
- BIG3 / BIG3-Region_Skane
- Keywords
- Prospective Cohort Study, Respiratory Function Tests, Computed Tomography, Electrocardiography, Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 16 Oct 2013 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Oct 2011 (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 an observational study aiming to identify and validate biomarkers (including imaging and clinical descriptors) for chronic obstructive pulmonary disease (COPD), cardiovascular disease (CVD) and lung cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exposed | – | –current daily smokers 100 cigarettes or more during lifetime |
| unexposed | – | –current non-smokers |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample,residents in Skåne county Sweden.
Key inclusion criteria (1 listed)
- 45-75 years
Key exclusion criteria (0 listed)
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
Not reported in the source record.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Background: PubMed 19017732Gerhardsson de Verdier M. The big three concept: a way to tackle the health care crisis? Proc Am Thorac Soc. 2008 Dec 1;5(8):800-5. doi: 10.1513/pats.200806-058TH.
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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.
Louise Hagman Bennet, MD, PhD study chair
Skane University Hospital
David Erlinge, MD, PhD principal investigator
Skane University Hospital
Claes-Göran Löfdahl, MD, PhD principal investigator
Skane University Hospital
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 Diseases, run by Region Skane 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 0 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: enrolling by invitation, as of the sponsor's last update on 29 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01460264, which also lists 1 linked publication.
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 29 Aug 2025.