E-cigarettesNCT03153228
Acute Response to Cigarette and E-cigarette Smoking Assesed in Exhaled Breath Condensate in Healthy Smokers of Traditional and E-cigarettes
An observational study of E-cigarettes, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Electronical cigarettes, also known as "e-cigarettes" are a new phenomenon, which steadily wins more aprobation among smokers. However, there exists no much data concerning the effects of acute exposure to electronic cigarettes vapour on the respiratory system. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- E-cigarettes
- How many people
- 87 participants
- Where
- 1 sitePoland
- Study dates
- 8 May 2017to Oct 2018
- Phase
- Observational
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy smokers of traditional cigarettes, healthy smokers of e-cigarettes, healthy nonsmoking volunteers
Who may be able to join
- healthy smokers of traditional cigarettes - min. 1 packyear
- healthy smokers of e-cigarettes - min. 1 year of smoking history
- control group - healthy nonsmoking volunteers without any history of lung disease
Who cannot join
- age below 18 years
- inhaled corticosteroid therapy at least 6 weeks prior to study enrollment
- any co-morbidities
- respiratory infections at least 6 weeks prior to study enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison of Biomarkers of Acute Response to Cigarette Smoking and E-cigarettes Smoking Assesed in Exhaled Breath Condensate in Healthy Smokers of Traditional and Electronical Cigarettes.
Electronical cigarettes, also known as "e-cigarettes" are a new phenomenon, which steadily wins more aprobation among smokers. However, there exists no much data concerning the effects of acute exposure to electronic cigarettes vapour on the respiratory system.
The aim of the present study is to evaluate and compare the acute response to electronic and traditional cigarettes in healthy smokers.
Read the detailed description
The aim of the study is:
- to evaluate the acute response to traditional cigarettes on the respiratory system
- to evaluate the acute response to electronic cigarettes on the respiratory system
- to assess the relationship between the type of smoked cigarettes (traditional vs. electronic) and concentration of markers of airway inflammation released in healthy smokers
Material and methods:
- 29 healthy smokers of traditional cigarettes
- 29 healthy smokers of electronic cigarettes
- 29 healthy, nonsmoking volunteers
After 8 hours of smoking abstinence:
- the spirometry test
- the first collection of the exhaled breath condensate (EBC I)
- smoking a traditional / electronic cigarette
- the second collection of the exhaled breath condensate (EBC II) - one hour after smoking
- the third collection of the exhaled breath condensate (EBC III) - six hours after smoking
- the measurement of biomarkers of oxidative stress in the EBC (isoprostane-8, malondialdehyde MDA, IL-8) and pH of the EBC
- Conditions
- E-cigarettes
- Keywords
- E-cigarettes
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Smokers of traditional cigarettes | 29 healthy smokers of traditional cigarettes (min. 1 packyear) | |
| Smokers of e-cigarettes | 29 healthy smokers of e-cigarettes (min. 1 packyear) | |
| Control | 29 healthy volunteers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory markers in exhaled breath condensate
Inflammatory markers in exhaled breath condensate in healthy subjects, smokers of traditional cigarettes and e-cigarette smokers
Measured: Approximately 1-2 months after completion of study procedures in all patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start8 May 2017
- Primary completionJul 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for E-cigarettesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153228
- Sponsor's protocol ID
- IPU-DIMPA-WUM13(2)
- Status last verified
- May 2017
- First submitted
- 12 May 2017
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Biomarkers of Acute Response to Cigarette Smoking and E-cigarettes Smoking Assesed in Exhaled Breath Condensate in Healthy Smokers of Traditional and Electronical Cigarettes.
- ClinicalTrials.gov ID
- NCT03153228
- Acronym / sponsor ID
- IPU-DIMPA-WUM13(2)
- Conditions
- E-cigarettes
- Keywords
- E-cigarettes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 8 May 2017 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 15 May 2017 (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.
Electronical cigarettes, also known as "e-cigarettes" are a new phenomenon, which steadily wins more aprobation among smokers. However, there exists no much data concerning the effects of acute exposure to electronic cigarettes vapour on the respiratory system.
The aim of the present study is to evaluate and compare the acute response to electronic and traditional cigarettes in healthy smokers.
Detailed description
The aim of the study is:
- to evaluate the acute response to traditional cigarettes on the respiratory system
- to evaluate the acute response to electronic cigarettes on the respiratory system
- to assess the relationship between the type of smoked cigarettes (traditional vs. electronic) and concentration of markers of airway inflammation released in healthy smokers
Material and methods:
- 29 healthy smokers of traditional cigarettes
- 29 healthy smokers of electronic cigarettes
- 29 healthy, nonsmoking volunteers
After 8 hours of smoking abstinence:
- the spirometry test
- the first collection of the exhaled breath condensate (EBC I)
- smoking a traditional / electronic cigarette
- the second collection of the exhaled breath condensate (EBC II) - one hour after smoking
- the third collection of the exhaled breath condensate (EBC III) - six hours after smoking
- the measurement of biomarkers of oxidative stress in the EBC (isoprostane-8, malondialdehyde MDA, IL-8) and pH of the EBC
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Smokers of traditional cigarettes | – | –29 healthy smokers of traditional cigarettes (min. 1 packyear) |
| Smokers of e-cigarettes | – | –29 healthy smokers of e-cigarettes (min. 1 packyear) |
| Control | – | –29 healthy volunteers. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy smokers of traditional cigarettes, healthy smokers of e-cigarettes, healthy nonsmoking volunteers
Key inclusion criteria (3 listed)
- healthy smokers of traditional cigarettes - min. 1 packyear
- healthy smokers of e-cigarettes - min. 1 year of smoking history
- control group - healthy nonsmoking volunteers without any history of lung disease
Key exclusion criteria (4 listed)
- age below 18 years
- inhaled corticosteroid therapy at least 6 weeks prior to study enrollment
- any co-morbidities
- respiratory infections at least 6 weeks prior to study enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inflammatory markers in exhaled breath condensate
Time frame: Approximately 1-2 months after completion of study procedures in all patients
Inflammatory markers in exhaled breath condensate in healthy subjects, smokers of traditional cigarettes and e-cigarette smokers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of E-cigarettes, run by Medical University of Warsaw at 1 site in Poland.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Inflammatory markers in exhaled breath condensate (time frame: Approximately 1-2 months after completion of study procedures in all patients). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2017.