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NCT Number: NCT03049202

BROnchoalveolar Investigations of Never-smokers With Chronic Obstruction 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.

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Airway Obstruction Behavior Bronchial Diseases Bronchitis Bronchitis, Chronic Chronic Bronchitis Chronic Disease Coitus Disease Attributes Emphysema Gender Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Sexual Behavior Smoking Smoking, Tobacco Tobacco Smoking Tobacco Use

Age range

50 year–68 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska Institutet/Karolinska University Hospital Solna, Stockholm, Sverige, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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

  2. Emphysema, as shown on chest CT scan

    Time frame: Measured at baseline

    Based on lung densities < (-950) Hounsfield units (HU)

  3. Airway wall thickness on chest CT scan

    Time frame: Measured at baseline

    Based on lung densities in the range of (-750) - (-900) HU

  4. 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

  5. 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)

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Göteborg University
  • Karolinska University Hospital
  • Linkoeping University
  • Lund University
  • Lund University Hospital
  • Region Stockholm
  • Sahlgrenska University Hospital
  • Swedish Heart Lung Foundation
  • Umeå University
  • University Hospital, Linkoeping
  • University Hospital, Umeå
  • Uppsala University
  • Uppsala University Hospital

Registry information

Official study title

BROnchoalveolar Investigations of Never-smokers With CHronic Obstructive Lung Disease From the Swedish CardioPulmonary bioImage Study

Acronym: BRONCOSCAPIS

Important dates

Study start
2017
Primary completion
2024
Study completion
2030
First posted
Feb 9, 2017
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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