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NCT03049202Active, not recruiting

BROnchoalveolar Investigations of Never-smokers With Chronic Obstruction From the Swedish CardioPulmonary bioImage Study

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

Source: ClinicalTrials.gov · Last updated 2 Apr 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
1000 (estimated)
First submitted
31 Jan 2017
Start date
1 Feb 2017
Primary completion date
30 Jun 2024
Lead sponsor
Karolinska Institutet
Diseases
COPD
NCT number
NCT03049202

What you commit to

  • Study type: Observational
  • Planned participants: 1000
  • From 1 Feb 2017 to the primary completion date, 30 Jun 2024
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Received antibiotics in the 3 months prior to study entry
  • Treatment with oral or inhaled glucocorticoids within past 3 months prior to study entry

Other illness

  • Other lung diseases

Other

  • Smoking (for never-smoker groups)

Who the study is looking for

  • 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.

Age in the registry: 50 years to 68 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Göteborg University / Sahlgrenska University Hospital
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GothenburgSwedenUnknown status
Linköping Unversity /Linköping University Hospital
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LinköpingSwedenUnknown status
Lund University / Lund University Hospital
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LundSwedenUnknown status
Karolinska Institutet/Karolinska University Hospital Solna
Coordinator of this site? Confirm its status
StockholmSwedenUnknown status
Umeå University, Umeå University Hospital
Coordinator of this site? Confirm its status
UmeåSwedenUnknown status
Uppsala University / Uppsala University Hospital
Coordinator of this site? Confirm its status
UppsalaSwedenUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.