BROnchoalveolar Investigations of Never-smokers With Chronic Obstruction From the Swedish CardioPulmonary bioImage Study (BRONCOSCAPIS)
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|ClinicalTrials.gov Identifier: NCT03049202|
Recruitment Status : Recruiting
First Posted : February 9, 2017
Last Update Posted : December 11, 2019
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.
|Condition or disease|
|Chronic Obstructive Pulmonary Disease Emphysema Chronic Bronchitis Airway Obstruction Smoking, Tobacco Gender|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||BROnchoalveolar Investigations of Never-smokers With CHronic Obstructive Lung Disease From the Swedish CardioPulmonary bioImage Study|
|Actual Study Start Date :||February 1, 2017|
|Estimated Primary Completion Date :||June 1, 2020|
|Estimated Study Completion Date :||December 31, 2025|
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.
- 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)
- Molecular phenotypes of never-smoker COPD group(s) as compared to control groups [ Time Frame: Measured at baseline ]mRNA, miRNA, proteomes, lipidomes and metabolomes will be quantified from airway exudates (BAL fluid), BAL cells, and airway epithelium (bronchial brushings)
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03049202
|Contact: Magnus Skold, MD, PhD||+46 8 517 748 email@example.com|
|Contact: Asa M Wheelock, PhD||+46 8 517 firstname.lastname@example.org|
|Karolinska Institutet/Karolinska University Hospital Solna||Recruiting|
|Stockholm, Sverige, Sweden, 17176|
|Contact: Magnus Skold, MD, PhD email@example.com|
|Contact: Asa M Wheelock, PhD firstname.lastname@example.org|
|Principal Investigator: C. Magnus Skold, MD, PhD|
|Principal Investigator: Asa M Wheelock, PhD|
|Göteborg University / Sahlgrenska University Hospital||Recruiting|
|Contact: Anders Andersson, MD|
|Contact: Sara Tengvall, MD, PhD|
|Linköping Unversity /Linköping University Hospital||Recruiting|
|Contact: Lennart Persson, MD|
|Lund University / Lund University Hospital||Recruiting|
|Contact: Leif Bjermer, MD|
|Contact: Ellen Tufvesson, PhD|
|Umeå University / Umeå University Hospital||Recruiting|
|Contact: Anders Blomberg, MD|
|Uppsala University / Uppsala University Hospital||Recruiting|
|Contact: Christer Janson, MD|
|Contact: Helena Igelström, MD|
|Principal Investigator:||Magnus Skold, MD, PhD||Karolinska Institutet /Karolinska University Hospital|