SmokersAerotox-1NCT03608293
Smoker Extracellular Vesicles Influence on Human Bronchial Epithelial Cells
A study testing Broncho Alveolar Lavages (BAL) in people with Smokers and Human Bronchial Epithelial Cells, run by Lille Catholic University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smokers, Human Bronchial Epithelial Cells, Lung Pathogenesis
- What is being tested?
- Broncho Alveolar Lavages (BAL)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 31 Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 year-old
Who cannot join
- Lack of informed consent
- Drug treatment
- Professional exposure
- Evolutive pregnancy
- Bradycardia
- Respiratory assistance required,
Show all 9Show fewer
- Diagnosed respiratory distress (e.g. COPD, asthma)
- Infectious pneumopathy
- Bronchial cancer
About this study
Official title: Particulate Air Pollution : Smoker Extracellular Vesicles Influence on Human Bronchial Epithelial Cells
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.
Read more
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).
- Being tested
- Broncho Alveolar Lavages (BAL)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broncho Alveolar Lavages (BAL)Diagnostic test
BEAS-2 B cells are exposed to EVs isolated from BAL of smokers and non-smokers.
| Study group | Role | What they receive |
|---|---|---|
| Smokers | Experimental | Smokers outpatients at the Pneumology service from the HôpitalSaint-Philibert (Lomme, France) to whom a bronchoalveolar lavage will be performed Receives: Diagnostic Test: Broncho Alveolar Lavages (BAL) |
| Non smokers | Active comparator | Non smokers outpatients at the Pneumology service from the HôpitalSaint-Philibert (Lomme, France) to whom a bronchoalveolar lavage will be performed Receives: Diagnostic Test: Broncho Alveolar Lavages (BAL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through the study completion, an average of 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start1 Jan 2012
- Primary completion31 Jul 2013
- Study completion31 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- Universite du Littoral Cote d'Opale
- Responsible party
- Sponsor
- Investigators
- Pierre Gosset, MD, Principal investigator, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608293
- Sponsor's protocol ID
- RC-P0014
- Acronym
- Aerotox-1
- Status last verified
- Jun 2026
- First submitted
- 24 Jul 2018
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Particulate Air Pollution : Smoker Extracellular Vesicles Influence on Human Bronchial Epithelial Cells
- ClinicalTrials.gov ID
- NCT03608293
- Acronym / sponsor ID
- Aerotox-1 / RC-P0014
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- Universite du Littoral Cote d'Opale
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Jul 2013 (actual)
- Study completion
- 31 Dec 2013 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smokers | Experimental | Diagnostic Test: Broncho Alveolar Lavages (BAL)Smokers outpatients at the Pneumology service from the HôpitalSaint-Philibert (Lomme, France) to whom a bronchoalveolar lavage will be performed |
| Non smokers | Active comparator | Diagnostic Test: Broncho Alveolar Lavages (BAL)Non smokers outpatients at the Pneumology service from the HôpitalSaint-Philibert (Lomme, France) to whom a bronchoalveolar lavage will be performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- >18 year-old
Key exclusion criteria (9 listed)
- Lack of informed consent
- Drug treatment
- Professional exposure
- Evolutive pregnancy
- Bradycardia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Broncho Alveolar Lavages (BAL)BEAS-2 B cells are exposed to EVs isolated from BAL of smokers and non-smokers. | Diagnostic test | Non smokers, Smokers |
Primary outcome
Quantification of target mRNA expression in human bronchial epithelial cells (BEAS-2 B) exposed to EVs isolated from LBA of patients
Time frame: Through the study completion, an average of 48 months
Quantitative polymerase chain reaction (RT-qPCR) for determination of mRNA expression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Results publication: PubMed 28063900Heliot 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Gosset, MD principal investigator
GHICL
Questions about this trial
What is this clinical trial studying?
A study testing Broncho Alveolar Lavages (BAL) in people with Smokers and Human Bronchial Epithelial Cells, run by Lille Catholic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of target mRNA expression in human bronchial epithelial cells (BEAS-2 B) exposed to EVs isolated from LBA of patients (time frame: Through the study completion, an average of 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03608293, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.