Chronic Obstructive Pulmonary DiseaseBRONCOSCAPISNCT03049202
BROnchoalveolar Investigations of Never-smokers With Chronic Obstruction From the Swedish CardioPulmonary bioImage Study
An observational study of Chronic Obstructive Pulmonary Disease and Emphysema, run by Karolinska Institutet at 6 sites in Sweden.
Trial summary
Obstructive lung disease is an increasing global health problem of pandemic proportions, with COPD alone affecting >10% of the population. Smoking is the main and most well studies risk factor for developing COPD. Read more about this study
- Who is it for?
- Ages 50 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Emphysema, Chronic Bronchitis
- How many people
- 1,000 participants
- Where
- 6 sitesSweden
- Study dates
- 1 Feb 2017to 31 Dec 2030
- 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 50 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The 1000 participants are recruited from the Swedish SCAPIS study, a cross sectional study screening 30,000 subjects across the six University Hospitals in Sweden, based on lung function criteria and questionnaire criteria collected during SCAPIS.
Who may be able to join
- Spirometry of postbronchodilator forced expiratory volume in 1 second (FEV1) >50% of predicted level for all groups.
- Spirometry of postbronchodilator FEV1 >80% of predicted level and FEV1/FVC ratio >0.70 for Healthy control groups
- Spirometry of postbronchodilator FEV1/FVC ratio <0.70 for COPD groups.
Who cannot join
- Smoking (for never-smoker groups)
- Other lung diseases
- Received antibiotics in the 3 months prior to study entry
- Treatment with oral or inhaled glucocorticoids within past 3 months prior to study entry
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Sweden6 sites
Göteborg University / Sahlgrenska University Hospital
Gothenburg
Linköping Unversity /Linköping University Hospital
Linköping
Lund University / Lund University Hospital
Lund
Karolinska Institutet/Karolinska University Hospital Solna
Stockholm, Sverige, 17176
Umeå University / Umeå University Hospital
Umeå
Uppsala University / Uppsala University Hospital
Uppsala
About this study
Official title: BROnchoalveolar Investigations of Never-smokers With CHronic Obstructive Lung Disease From the Swedish CardioPulmonary bioImage Study
Obstructive lung disease is an increasing global health problem of pandemic proportions, with COPD alone affecting >10% of the population. Smoking is the main and most well studies risk factor for developing COPD. However, chronic airway obstruction also in never-smoking populations has recently been recognized as an increasing health problem.
In the clinical segment (PI: Prof. C. Magnus Skold), 1000 subjects from the Swedish national SCAPIS study will be clinically well characterized in one of the six Swedish University Hospital Respiratory clinics (clinical site PIs: Anders Andersson, Leif Bjermer, Anders Blomberg, Christer Janson, Lennart Persson, Magnus Skold). This first screening includes all never-smokers with COPD identified in the SCAPIS study. A subset of 300 subjects from the groups of Healthy never-smokers, current-smokers with normal lung function, current-smokers with COPD, ex-smokers with COPD, and never-smokers with COPD will be selected for the Bronchoscopy segment, were sampling will be performed from a number of anatomical locations, including bronchial biopsies, airway epithelial brushings, and bronchoalveolar lavage. Serum, plasma, and urine samples will also be collected.
Read more
In the systems medicine segment (PI: Assoc. prof Asa M. Wheelock), alterations at the epigenetic, mRNA, microRNA, proteome, metabolome and microbiome level will be performed from multiple lung compartments (airway epithelium, alveolar macrophages, exosomes, and bronchoalveolar exudates). By means of biostatistics and bioinformatics approaches, specific mediators and molecular pathways critical in the pathological mechanisms of obstructive lung disease related to never-smoker disease phenotypes will be identified.
In the immunohistochemistry segment (PI: Prof. Jonas Erjefalt), a number of molecules of relevance for disease pathology will be investigated in bronchial biopsies collected from the 300 subjects in the Bronchoscopy segment.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is an umbrella diagnosis defined by obstructive lung function impairments, and is likely to be caused by a multitude of etiologies including environmental exposures, genetic predispositions and developmental factors. Due to the heterogeneity of the disease, molecular and mechanistic sub-phenotyping of COPD represents an essential step to facilitate the development of relevant diagnostic and treatment options for this constantly growing patient group. In the BRONCHO-SCAPIS study, molecular sub-phenotypes of smoking-induced COPD are investigated. A particular focus relates to recent epidemiological indications of an increasing proportion of never-smokers developing the disease. The study encompasses profiling of mRNA, miRNA, proteomes, metabolomes and lipid mediators of from multiple lung compartments (airway epithelium, alveolar macrophages, exosomes, and bronchoalveolar exudates) using a range of 'omics platforms, in combination with extensive clinical phenotyping of early stage COPD patients, never-smokers, and smokers with normal lung function from both genders. The primary objective of the study is to identify molecular sub-phenotypes of never-smokers with COPD, specifically by correlating clinical phenotypes multi-molecular 'omics profiling from multiple lung compartments of early stage COPD patients compared to healthy and at-risk control populations. Secondary goals involve identification of subsets of prognostic/diagnostic biomarkers for classification of the defined subgroups, as well as relevant pharmaceutical targets.
- Conditions
- Chronic Obstructive Pulmonary Disease, Emphysema, Chronic Bronchitis, Airway Obstruction, Smoking, Tobacco, Gender
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema, Bronchitis, Chronic, Airway Obstruction, Tobacco Smoking, Coitus
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 |
|---|---|---|
| Never-smoker COPD participants | COPD patients with mild-to-moderate COPD (GOLD I-II) that have never smoked. Definition of never-smoker: Lifetime consumption of <100 cigarettes. No cigarettes the past 2 years. | |
| Ex-smoker COPD participants | COPD patients with mild-to-moderate COPD (GOLD I-II) that stopped smoking. Definition of smoking: > 10 pack years. Definition of ex-smoker: > 2 years since smoke cessation. | |
| Current-smoker COPD participants | COPD patients with mild-to-moderate COPD (GOLD I-II) that are currently smoking. Definition of smoking: > 10 pack years. Definition of current-smoker: > 10/cigarettes/dat the past 6 months. | |
| Current-smoker healthy controls | Current-smokers that are otherwise healthy, with normal lung function. Definition of smoking: > 10 pack years. Definition of current-smoker: > 10/cigarettes/dat the past 6 months. | |
| Never-smoker healthy controls | Healthy participants that have never smoked. Definition of never-smoker: Lifetime consumption of <100 cigarettes. No cigarettes the past 2 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in 1 second (FEV1)
Calculated as percent predicted based on the European Coal and Steel Community reference values
Measured: Measured at baseline
Emphysema, as shown on chest CT scan
Based on lung densities < (-950) Hounsfield units (HU)
Measured: Measured at baseline
Airway wall thickness on chest CT scan
Based on lung densities in the range of (-750) - (-900) HU
Measured: Measured at baseline
COPD status (COPD participants versus control group participants) based on GOLD criteria
Calculated using, post-bronchodilator values defined as meeting the criteria based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) of a fixed FEV1/forced vital capacity (FVC) ratio < 0.7
Measured: Measured at baseline
COPD status (COPD participants versus control group participants) based on GLI criteria
Calculated using, post-bronchodilator values defined as meeting the Global Lung Initiative (GLI) ratio of FEV1/FVC below of lowest limit of normal z-score < (-1.64)
Measured: Measured at baseline
Secondary outcomes (1)
Molecular phenotypes of never-smoker COPD group(s) as compared to control groups
mRNA, miRNA, proteomes, lipidomes and metabolomes will be quantified from airway exudates (BAL fluid), BAL cells, and airway epithelium (bronchial brushings)
Measured: Measured at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start1 Feb 2017
- Primary completion30 Jun 2024
- Study completion31 Dec 2030 (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.
- More trials run by Karolinska InstitutetThe 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
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Heart Lung Foundation, Lund University, Göteborg University, Linkoeping University, Uppsala University, Umeå University, Karolinska University Hospital, Lund University Hospital, Sahlgrenska University Hospital, University Hospital, Linkoeping, Uppsala University Hospital, University Hospital, Umeå, Region Stockholm
- Responsible party
- Principal investigator, Asa Wheelock, Karolinska Institutet
- Investigators
- Magnus Skold, MD, PhD, Principal investigator, Karolinska Institutet /Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049202
- Sponsor's protocol ID
- 2016/841-31/2
- Acronym
- BRONCOSCAPIS
- Status last verified
- Mar 2025
- First submitted
- 31 Jan 2017
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sonnerfors P, Jacobson PK, Andersson A, Bjermer LH, Blomberg A, Blomqvist H, Erjefalt JS, Kolosenko I, Malinovschi A, Pincikova T, Tufvesson E, Wheelock AM, Janson C, Persson HL, Skold M. Characterisation of chronic obstructive pulmonary disease (COPD) in never-smokers and ever-smokers from a population-based cohort. BMJ Open Respir Res. 2026 Feb 27;13(1):e003578. doi: 10.1136/bmjresp-2025-003578.
PubMed 41760355
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BROnchoalveolar Investigations of Never-smokers With CHronic Obstructive Lung Disease From the Swedish CardioPulmonary bioImage Study
- ClinicalTrials.gov ID
- NCT03049202
- Acronym / sponsor ID
- BRONCOSCAPIS / 2016/841-31/2
- Conditions
- Chronic Obstructive Pulmonary Disease, Emphysema, Chronic Bronchitis, Airway Obstruction, Smoking, Tobacco, Gender
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Swedish Heart Lung Foundation, Lund University, Göteborg University, Linkoeping University, Uppsala University, Umeå University, Karolinska University Hospital, Lund University Hospital, Sahlgrenska University Hospital, University Hospital, Linkoeping, Uppsala University Hospital, University Hospital, Umeå, Region Stockholm
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 9 Feb 2017 (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.
Obstructive lung disease is an increasing global health problem of pandemic proportions, with COPD alone affecting >10% of the population. Smoking is the main and most well studies risk factor for developing COPD. However, chronic airway obstruction also in never-smoking populations has recently been recognized as an increasing health problem.
In the clinical segment (PI: Prof. C. Magnus Skold), 1000 subjects from the Swedish national SCAPIS study will be clinically well characterized in one of the six Swedish University Hospital Respiratory clinics (clinical site PIs: Anders Andersson, Leif Bjermer, Anders Blomberg, Christer Janson, Lennart Persson, Magnus Skold). This first screening includes all never-smokers with COPD identified in the SCAPIS study. A subset of 300 subjects from the groups of Healthy never-smokers, current-smokers with normal lung function, current-smokers with COPD, ex-smokers with COPD, and never-smokers with COPD will be selected for the Bronchoscopy segment, were sampling will be performed from a number of anatomical locations, including bronchial biopsies, airway epithelial brushings, and bronchoalveolar lavage. Serum, plasma, and urine samples will also be collected.
In the systems medicine segment (PI: Assoc. prof Asa M. Wheelock), alterations at the epigenetic, mRNA, microRNA, proteome, metabolome and microbiome level will be performed from multiple lung compartments (airway epithelium, alveolar macrophages, exosomes, and bronchoalveolar exudates). By means of biostatistics and bioinformatics approaches, specific mediators and molecular pathways critical in the pathological mechanisms of obstructive lung disease related to never-smoker disease phenotypes will be identified.
In the immunohistochemistry segment (PI: Prof. Jonas Erjefalt), a number of molecules of relevance for disease pathology will be investigated in bronchial biopsies collected from the 300 subjects in the Bronchoscopy segment.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is an umbrella diagnosis defined by obstructive lung function impairments, and is likely to be caused by a multitude of etiologies including environmental exposures, genetic predispositions and developmental factors. Due to the heterogeneity of the disease, molecular and mechanistic sub-phenotyping of COPD represents an essential step to facilitate the development of relevant diagnostic and treatment options for this constantly growing patient group. In the BRONCHO-SCAPIS study, molecular sub-phenotypes of smoking-induced COPD are investigated. A particular focus relates to recent epidemiological indications of an increasing proportion of never-smokers developing the disease. The study encompasses profiling of mRNA, miRNA, proteomes, metabolomes and lipid mediators of from multiple lung compartments (airway epithelium, alveolar macrophages, exosomes, and bronchoalveolar exudates) using a range of 'omics platforms, in combination with extensive clinical phenotyping of early stage COPD patients, never-smokers, and smokers with normal lung function from both genders. The primary objective of the study is to identify molecular sub-phenotypes of never-smokers with COPD, specifically by correlating clinical phenotypes multi-molecular 'omics profiling from multiple lung compartments of early stage COPD patients compared to healthy and at-risk control populations. Secondary goals involve identification of subsets of prognostic/diagnostic biomarkers for classification of the defined subgroups, as well as relevant pharmaceutical targets.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Never-smoker COPD participants | – | –COPD patients with mild-to-moderate COPD (GOLD I-II) that have never smoked. Definition of never-smoker: Lifetime consumption of <100 cigarettes. No cigarettes the past 2 years. |
| Ex-smoker COPD participants | – | –COPD patients with mild-to-moderate COPD (GOLD I-II) that stopped smoking. Definition of smoking: > 10 pack years. Definition of ex-smoker: > 2 years since smoke cessation. |
| Current-smoker COPD participants | – | –COPD patients with mild-to-moderate COPD (GOLD I-II) that are currently smoking. Definition of smoking: > 10 pack years. Definition of current-smoker: > 10/cigarettes/dat the past 6 months. |
| Current-smoker healthy controls | – | –Current-smokers that are otherwise healthy, with normal lung function. Definition of smoking: > 10 pack years. Definition of current-smoker: > 10/cigarettes/dat the past 6 months. |
| Never-smoker healthy controls | – | –Healthy participants that have never smoked. Definition of never-smoker: Lifetime consumption of <100 cigarettes. No cigarettes the past 2 years. |
Who may qualify
- Ages
- 50 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The 1000 participants are recruited from the Swedish SCAPIS study, a cross sectional study screening 30,000 subjects across the six University Hospitals in Sweden, based on lung function criteria and questionnaire criteria collected during SCAPIS.
Key inclusion criteria (3 listed)
- Spirometry of postbronchodilator forced expiratory volume in 1 second (FEV1) >50% of predicted level for all groups.
- Spirometry of postbronchodilator FEV1 >80% of predicted level and FEV1/FVC ratio >0.70 for Healthy control groups
- Spirometry of postbronchodilator FEV1/FVC ratio <0.70 for COPD groups.
Key exclusion criteria (4 listed)
- Smoking (for never-smoker groups)
- Other lung diseases
- Received antibiotics in the 3 months prior to study entry
- Treatment with oral or inhaled glucocorticoids within past 3 months prior to study entry
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
Forced expiratory volume in 1 second (FEV1)
Time frame: Measured at baseline
Calculated as percent predicted based on the European Coal and Steel Community reference values
Emphysema, as shown on chest CT scan
Time frame: Measured at baseline
Based on lung densities < (-950) Hounsfield units (HU)
Airway wall thickness on chest CT scan
Time frame: Measured at baseline
Based on lung densities in the range of (-750) - (-900) HU
COPD status (COPD participants versus control group participants) based on GOLD criteria
Time frame: Measured at baseline
Calculated using, post-bronchodilator values defined as meeting the criteria based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) of a fixed FEV1/forced vital capacity (FVC) ratio < 0.7
COPD status (COPD participants versus control group participants) based on GLI criteria
Time frame: Measured at baseline
Calculated using, post-bronchodilator values defined as meeting the Global Lung Initiative (GLI) ratio of FEV1/FVC below of lowest limit of normal z-score < (-1.64)
1 secondary outcome
Molecular phenotypes of never-smoker COPD group(s) as compared to control groups
Time frame: Measured at baseline
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 2 Apr 2025.
- Derived from this study: PubMed 41760355Sonnerfors P, Jacobson PK, Andersson A, Bjermer LH, Blomberg A, Blomqvist H, Erjefalt JS, Kolosenko I, Malinovschi A, Pincikova T, Tufvesson E, Wheelock AM, Janson C, Persson HL, Skold M. Characterisation of chronic obstructive pulmonary disease (COPD) in never-smokers and ever-smokers from a population-based cohort. BMJ Open Respir Res. 2026 Feb 27;13(1):e003578. doi: 10.1136/bmjresp-2025-003578.
- Individual participant dataSharing planned: No
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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.
Magnus Skold, MD, PhD principal investigator
Karolinska Institutet /Karolinska University Hospital
6 sites 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 Emphysema, run by Karolinska Institutet at 6 sites 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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
What does the primary outcome measure?
Forced expiratory volume in 1 second (FEV1) (time frame: Measured at baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03049202, 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 2 Apr 2025.