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CompletedNCT03608293Aerotox-1Updated Jun 11, 2026

Smoker Extracellular Vesicles Influence on Human Bronchial Epithelial Cells

An interventional study of Broncho Alveolar Lavages (BAL) in Smokers, Human Bronchial Epithelial Cells and Lung Pathogenesis, sponsored by Lille Catholic University. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-11.

Sponsored by Lille Catholic University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 6 years 6 months after the study started (first participant enrolled Jan 2012, registered Jul 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Cigarette smoking is a habit that has spread all over the world and is a significant risk factor for many diseases including cardiovascular disease, chronic obstructive pulmonary disease(COPD),asthma and lung cancer.

Evaluation and understanding of tobacco health effects are of major interest worldwide and answer to important societal concerns.

Identification of new biomarkers of exposure to tobacco smoke potentially implicated in COPD or lung carcinogenesis would allow a better observation of tobacco exposed population, thanks to screening establishment at reversible stages of pathological processes.

In this study, the main goal is to study whether cigarettes smoking alters miRNA profiles of extracellular vesicles (EVs) present in human broncho alveolar lavages (BALs), which could affect surrounding normal bronchial epithelial cells status.

Read the detailed description

Extracellular vesicles (EVs) include a variety of nanoscale membranous vesicles (exosomes, microvesicles, microparticles). EVs are released into the interstitial fluid from a wide variety of normal or diseased cells.

Analysis of EVs and their content maybe useful as disease biomarkers as they reflect the contents of cells of origin, differ between normal and diseased tissue and can be reliably detected.

EVs may thus act as biomarkers of diverse pathologies like cancer, and detection of these biomarkers maybe applied to early diagnosis or assessment of prognosis in patients with cancer. EVs indeed contain both mRNAs and non-coding RNAs, such as small regulatory microRNAs (miRNAs).

02

Conditions studied

  • Smokers
  • Human Bronchial Epithelial Cells
  • Lung Pathogenesis
  • Biomarkers
03

In context

Lead sponsor

Lille Catholic University is the lead sponsor of 111 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • >18 year-old

Exclusion criteria

Exclusion Criteria:

  • Lack of informed consent
  • Drug treatment
  • Professional exposure
  • Evolutive pregnancy
  • Bradycardia
  • Respiratory assistance required,
  • Diagnosed respiratory distress (e.g. COPD, asthma)
  • Infectious pneumopathy
  • Bronchial cancer
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Smokers

    Smokers outpatients at the Pneumology service from the HôpitalSaint-Philibert (Lomme, France) to whom a bronchoalveolar lavage will be performed

    Diagnostic Test: Broncho Alveolar Lavages (BAL)

  • Active comparator
    Non smokers

    Non smokers outpatients at the Pneumology service from the HôpitalSaint-Philibert (Lomme, France) to whom a bronchoalveolar lavage will be performed

    Diagnostic Test: Broncho Alveolar Lavages (BAL)

Interventions

  • Diagnostic testBroncho Alveolar Lavages (BAL)

    BEAS-2 B cells are exposed to EVs isolated from BAL of smokers and non-smokers.

06

What researchers measure

Primary outcomes

  1. Quantification of target mRNA expression in human bronchial epithelial cells (BEAS-2 B) exposed to EVs isolated from LBA of patients

    Quantitative polymerase chain reaction (RT-qPCR) for determination of mRNA expression

    Time frame: Through the study completion, an average of 48 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Heliot A, Landkocz Y, Roy Saint-Georges F, Gosset P, Billet S, Shirali P, Courcot D, Martin PJ. Smoker extracellular vesicles influence status of human bronchial epithelial cells. Int J Hyg Environ Health. 2017 Apr;220(2 Pt B):445-454. doi: 10.1016/j.ijheh.2016.12.010. Epub 2016 Dec 30. PubMed 28063900 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03608293
Lead sponsor
Lille Catholic University
Collaborators
Universite du Littoral Cote d'Opale
Responsible party
Sponsor
First posted
Jul 31, 2018
Start date
Jan 1, 2012
Primary completion
Jul 31, 2013
Completion
Dec 31, 2013
Last update
Jun 11, 2026

Study contacts

Pierre Gosset, MD
principal investigator · GHICL

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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