An observational study in Chronic Obstructive Pulmonary Disease, Emphysema and Chronic Bronchitis, sponsored by Karolinska Institutet. Active, not recruiting at 6 sites in Sweden. Open to participants aged 50 Years to 68 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-02.
Sponsored by Karolinska Institutet · Observational
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.
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.
209 studies on the registry are indexed under Bronchitis, Chronic; 14 are open to participants now.
This study's planned enrollment of 1,000 is close to the median of 988 across 46 observational studies indexed under Bronchitis, Chronic.
Browse Bronchitis, Chronic studies →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
Compared within Bronchitis, Chronic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pulmonary Disease, Chronic Obstructive. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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-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.
Healthy participants that have never smoked. Definition of never-smoker: Lifetime consumption of \<100 cigarettes. No cigarettes the past 2 years.
Forced expiratory volume in 1 second (FEV1)
Calculated as percent predicted based on the European Coal and Steel Community reference values
Time frame: Measured at baseline
Emphysema, as shown on chest CT scan
Based on lung densities \< (-950) Hounsfield units (HU)
Time frame: Measured at baseline
Airway wall thickness on chest CT scan
Based on lung densities in the range of (-750) - (-900) HU
Time frame: 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
Time frame: 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)
Time frame: Measured at baseline
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)
Time frame: Measured at baseline
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2017 to primary completion in Jun 2024, 88 months.
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This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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