Electronic Cigarette UsePASVAPNCT04316234
Acute Health Effects of Passive Vape Among COPD Patients
A study testing Passive vape in people with Electronic Cigarette Use and Second Hand Smoke, run by University of Aarhus at 1 site in Denmark.
Trial summary
The use of e-cigarettes is often permitted in otherwise smoke-free areas causing passive vape exposure for present individuals. Little is known about the potential adverse health effects of passive vape, and people with respiratory diseases may be more susceptible. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Electronic Cigarette Use, Second Hand Smoke, Lung Function
- What is being tested?
- Passive vape
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2017to 30 Nov 2017
- 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
- Never smoker or ex-smokers ≥ 6 months
- Aged 18+
- A known diagnosis of COPD (FEV1/FVC < lower limit of normal, app. 70%)
- MRC ≥ 2 or CAT score ≥ 10
Who cannot join
- Exposure to smoking more than 30 min./day
- Treatment with inhaled or oral corticosteroids
- Known hypersensitivity to constituents in e-cigarettes
- Any other disease that could influence the study parameters
- Conditions that prevent safe access to the climate chambers (such as claustrophobia)
- Perennial rhinitis
- Deformed nasal airways
- Not being able to change from long-acting medication to short-acting medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Health Effects of Passive Exposure to Particles From Electronic Cigarettes - a Randomized Controlled Double-blinded Cross-over Trial Among COPD Patients
The use of e-cigarettes is often permitted in otherwise smoke-free areas causing passive vape exposure for present individuals. Little is known about the potential adverse health effects of passive vape, and people with respiratory diseases may be more susceptible.
The aim of the present study was to investigate local and systemic effects of short-term passive exposure to vape from e-cigarettes among patients with mild or moderate chronic obstructive pulmonary disease COPD in a randomized controlled double-blinded cross-over study.
Read the detailed description
Introduction: The use of e-cigarettes is often permitted in otherwise smoke-free areas causing passive vape exposure for present individuals. Little is known about the potential adverse health effects of passive vape, and people with respiratory diseases may be more susceptible.
Aim: to investigate local and systemic effects of short-term passive exposure to vape from e-cigarettes among patients with mild or moderate chronic obstructive pulmonary disease (COPD).
Design: In a randomised double-blinded cross-over study non-smoking COPD patients were exposed for four hours at two different exposure conditions separated by 14 days; A) clean filtered air and B) passive vaping under controlled environmental conditions.
Measurements: TSI P-TRAK Ultrafine Particle Counter was used for particle counts. Health effects, including lung function (FEV1/FVC) and fraction of exhaled nitric oxide (FeNO) were evaluated in relation to local and systemic effects prior to, right after and 24 h. after exposure.
Analysis: Mixed methods approach taking both time and exposure into account.
- Conditions
- Electronic Cigarette Use, Second Hand Smoke, Lung Function
- Being tested
- Passive vape
- Keywords
- Electronic cigarettes, Secondhand vape, Health effects, Lung function, Biomarkers, Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Vaping, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive vapeOther
On days with passive vape, 2-3 vapers in an adjacent chamber were vaping by turn, and vape was passed on to the exposure chamber continuously .
| Study group | Role | What they receive |
|---|---|---|
| A. Clean Air | No intervention | Clean air - no vaping was done. |
| B. Passive vaping | Experimental | E-cigarette users were present in an adjacent chamber during both exposures, but only in situation B they were vaping and the vape-polluted air was passed on to the exposure chamber. Receives: Other: Passive vape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Particles in Exhaled Air (Surfactant Protein A & Albumin)
PExA: Subjects performed repeated breath maneuvers allowing for airway closure and re-opening, and exhaled particles were optically counted and collected on a membrane using the (novel) PExA® instrument set-up.
Measured: At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)
Secondary outcomes (6)
Change in Lung Function (FEV1 & FVC)
Spirometry
Measured: At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)
Change in Fractional exhaled nitric oxide (FENO)
NIOX system; Aerocrine AB, Sweden
Measured: At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)
Change in Blood samples
IL-8, Nightingale analyses for biomarkers
Measured: At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)
Change in nasal volume (using Acoustic rhinometry)
Is used to assess the nasal cross sectional area and volume. The left and right nasal cavity were studied alternatively until three reproducible measurements were obtained. The minimum cross sectional cavity area was calculated from the means of the measurements. By integration of the area-distance curve, the sum of the volume 2 to 4 (vol2-4) from the nostril was determined on both sides.
Measured: At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)
Change in Symptom questionnaire
In the exposure chamber participants were asked to fill out a symptom questionnaire every 30 min. regarding their well-being and experienced symptoms in eyes, nose and mouth.
Measured: Every 30 min during 4 hours of exposure.
Change in biomarkers in Saliva Sample
An oral svap from Salivette was placed in the mouth of the participant to collect saliva by gently chewing the swab for one minute. Afterwards the saturated swab was removed to the suspended insert and closed firmly with a lid. Then the sample was transferred to a freezer and stored for -80 C until further analysis. The sample will be analyzed for biomarkers (amylase, cortisol, substance P, lysozyme and secretory IgA.)
Measured: At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start1 Mar 2017
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electronic Cigarette UseStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomised double-blinded cross-over study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Principal investigator, Torben Sigsgaard, University of Aarhus
- Investigators
- Karin R Laursen, MSc, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316234
- Sponsor's protocol ID
- 1711000
- Acronym
- PASVAP
- Status last verified
- Mar 2020
- First submitted
- 5 Feb 2020
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Health Effects of Passive Exposure to Particles From Electronic Cigarettes - a Randomized Controlled Double-blinded Cross-over Trial Among COPD Patients
- ClinicalTrials.gov ID
- NCT04316234
- Acronym / sponsor ID
- PASVAP / 1711000
- Conditions
- Electronic Cigarette Use, Second Hand Smoke, Lung Function
- Keywords
- Electronic cigarettes, Secondhand vape, Health effects, Lung function, Biomarkers, Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 20 Mar 2020 (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.
The use of e-cigarettes is often permitted in otherwise smoke-free areas causing passive vape exposure for present individuals. Little is known about the potential adverse health effects of passive vape, and people with respiratory diseases may be more susceptible.
The aim of the present study was to investigate local and systemic effects of short-term passive exposure to vape from e-cigarettes among patients with mild or moderate chronic obstructive pulmonary disease COPD in a randomized controlled double-blinded cross-over study.
Detailed description
Introduction: The use of e-cigarettes is often permitted in otherwise smoke-free areas causing passive vape exposure for present individuals. Little is known about the potential adverse health effects of passive vape, and people with respiratory diseases may be more susceptible.
Aim: to investigate local and systemic effects of short-term passive exposure to vape from e-cigarettes among patients with mild or moderate chronic obstructive pulmonary disease (COPD).
Design: In a randomised double-blinded cross-over study non-smoking COPD patients were exposed for four hours at two different exposure conditions separated by 14 days; A) clean filtered air and B) passive vaping under controlled environmental conditions.
Measurements: TSI P-TRAK Ultrafine Particle Counter was used for particle counts. Health effects, including lung function (FEV1/FVC) and fraction of exhaled nitric oxide (FeNO) were evaluated in relation to local and systemic effects prior to, right after and 24 h. after exposure.
Analysis: Mixed methods approach taking both time and exposure into account.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomised double-blinded cross-over study
| Arm | Type | Receives |
|---|---|---|
| A. Clean Air | No intervention | –Clean air - no vaping was done. |
| B. Passive vaping | Experimental | Other: Passive vapeE-cigarette users were present in an adjacent chamber during both exposures, but only in situation B they were vaping and the vape-polluted air was passed on to the exposure chamber. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Never smoker or ex-smokers ≥ 6 months
- Aged 18+
- A known diagnosis of COPD (FEV1/FVC < lower limit of normal, app. 70%)
- MRC ≥ 2 or CAT score ≥ 10
Key exclusion criteria (8 listed)
- Exposure to smoking more than 30 min./day
- Treatment with inhaled or oral corticosteroids
- Known hypersensitivity to constituents in e-cigarettes
- Any other disease that could influence the study parameters
- Conditions that prevent safe access to the climate chambers (such as claustrophobia)
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 |
|---|---|---|
| Passive vapeOn days with passive vape, 2-3 vapers in an adjacent chamber were vaping by turn, and vape was passed on to the exposure chamber continuously . | Other | B. Passive vaping |
Primary outcome
Change in Particles in Exhaled Air (Surfactant Protein A & Albumin)
Time frame: At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)
PExA: Subjects performed repeated breath maneuvers allowing for airway closure and re-opening, and exhaled particles were optically counted and collected on a membrane using the (novel) PExA® instrument set-up.
6 secondary outcomes
Change in Lung Function (FEV1 & FVC)
Time frame: At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)
Change in Fractional exhaled nitric oxide (FENO)
Time frame: At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)
Change in Blood samples
Time frame: At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)
Change in nasal volume (using Acoustic rhinometry)
Time frame: At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)
Change in Symptom questionnaire
Time frame: Every 30 min during 4 hours of exposure.
Change in biomarkers in Saliva Sample
Time frame: At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)
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 20 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Karin R Laursen, MSc principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive vape in people with Electronic Cigarette Use and Second Hand Smoke, run by University of Aarhus at 1 site in Denmark.
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 4 inclusion and 8 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 20 Mar 2020. 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 Denmark. 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?
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?
Change in Particles in Exhaled Air (Surfactant Protein A & Albumin) (time frame: At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)). 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 20 Mar 2020.