CoughPhase 4NCT02203162
Effect of Electronic Cigarette Use on Cough Reflex Sensitivity
A Phase 4 study testing electronic cigarette exposure in people with Cough, run by Montefiore Medical Center at 1 site in United States.
Trial summary
Although electronic cigarettes (e-cigs) are now widely used, very little information exists regarding the effect of electronic cigarette use (vaping) on the respiratory system. The aim of this study is to evaluate the acute effect of one e-cig vaping session (30 puffs 30 seconds apart) on cough reflex sensitivity in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cough
- What is being tested?
- electronic cigarette exposure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Dec 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- healthy adults (age18 years and above)
- nonsmokers
Who cannot join
- previous smoker
- asthma/other respiratory illness
- acute viral upper respiratory tract infection (common cold) in previous 4 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
Einstein Division/Montefiore Medical Center
The Bronx, New York, 10461
About this study
Although electronic cigarettes (e-cigs) are now widely used, very little information exists regarding the effect of electronic cigarette use (vaping) on the respiratory system. The aim of this study is to evaluate the acute effect of one e-cig vaping session (30 puffs 30 seconds apart) on cough reflex sensitivity in healthy adult nonsmokers.
Read the detailed description
30 adult nonsmokers will have their cough reflex sensitivity measured at baseline, 15 minutes after an e-cig vaping session, and 24 hours subsequently. One e-cig vaping session will consist of 30 puffs of an e-cg (Blu) 30 seconds apart, which will deliver the approximate nicotine amount delivered by one tobacco cigarette. Cough reflex sensitivity, defined as C5, the concentration of capsaicin inducing 5 or more coughs, is the standard end point of cough challenge studies.
- Conditions
- Cough
- Being tested
- electronic cigarette exposure
- Keywords
- cough, cough reflex sensitivity, electronic cigarette, capsaicin
- Medical subject headings
- Cough, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic cigarette exposureDevice
30 puffs of a disposable electronic cigarette, 30 seconds apart.
| Study group | Role | What they receive |
|---|---|---|
| cough reflex sensitivity | Experimental | electronic cigarette exposure Receives: Device: electronic cigarette exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cough Reflex Sensitivity (Log C5)
Measurement of cough reflex sensitivity to capsaicin (C5) performed 15 minutes and 24 hours after electronic cigarette use session. Changes in cough reflex sensitivity 15 minutes after e-cig use compared to baseline will be assessed. In addition, cough reflex sensitivity 24 hours after e-cig exposure will also be measured, so that duration of any changes noted after 15 minutes can be assessed. Increase in C5 means decrease in cough reflex sensitivity. Capsaicin cough challenge involves subjects breathing in incremental doubling concentrations of aerosolized capsaicin, 1 minute apart, until the concentration of capsaicin (micromolar) inducing 5 or more coughs (C5) is reached.
Measured: Baseline, 15 minutes, and 24 hours post-exposure to e-cig.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter V Dicpinigaitis, MD, Principal investigator, Montefiore Medical Center and Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203162
- Sponsor's protocol ID
- 2014-3288
- Status last verified
- Jun 2023
- First submitted
- 25 Jul 2014
- Last updated
- 28 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Results of this study have been published in January 2016 as a full manuscript.
Publications
Dicpinigaitis PV, Lee Chang A, Dicpinigaitis AJ, Negassa A. Effect of e-Cigarette Use on Cough Reflex Sensitivity. Chest. 2016 Jan;149(1):161-5. doi: 10.1378/chest.15-0817. Epub 2016 Jan 6.
PubMed 26291648
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electronic Cigarette Use on Cough Reflex Sensitivity
- ClinicalTrials.gov ID
- NCT02203162
- Acronym / sponsor ID
- 2014-3288
- Conditions
- Cough
- Keywords
- cough, cough reflex sensitivity, electronic cigarette, capsaicin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Jul 2014 (estimated)
- Results
- Posted 4 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although electronic cigarettes (e-cigs) are now widely used, very little information exists regarding the effect of electronic cigarette use (vaping) on the respiratory system. The aim of this study is to evaluate the acute effect of one e-cig vaping session (30 puffs 30 seconds apart) on cough reflex sensitivity in healthy adult nonsmokers.
Detailed description
30 adult nonsmokers will have their cough reflex sensitivity measured at baseline, 15 minutes after an e-cig vaping session, and 24 hours subsequently. One e-cig vaping session will consist of 30 puffs of an e-cg (Blu) 30 seconds apart, which will deliver the approximate nicotine amount delivered by one tobacco cigarette. Cough reflex sensitivity, defined as C5, the concentration of capsaicin inducing 5 or more coughs, is the standard end point of cough challenge studies.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cough reflex sensitivity | Experimental | Device: electronic cigarette exposureelectronic cigarette exposure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy adults (age18 years and above)
- nonsmokers
Key exclusion criteria (3 listed)
- previous smoker
- asthma/other respiratory illness
- acute viral upper respiratory tract infection (common cold) in previous 4 weeks
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 |
|---|---|---|
| electronic cigarette exposure30 puffs of a disposable electronic cigarette, 30 seconds apart. | Device | cough reflex sensitivity |
Primary outcome
Change in Cough Reflex Sensitivity (Log C5)
Time frame: Baseline, 15 minutes, and 24 hours post-exposure to e-cig.
Measurement of cough reflex sensitivity to capsaicin (C5) performed 15 minutes and 24 hours after electronic cigarette use session. Changes in cough reflex sensitivity 15 minutes after e-cig use compared to baseline will be assessed. In addition, cough reflex sensitivity 24 hours after e-cig exposure will also be measured, so that duration of any changes noted after 15 minutes can be assessed. Increase in C5 means decrease in cough reflex sensitivity. Capsaicin cough challenge involves subjects breathing in incremental doubling concentrations of aerosolized capsaicin, 1 minute apart, until the concentration of capsaicin (micromolar) inducing 5 or more coughs (C5) is reached.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26291648Dicpinigaitis PV, Lee Chang A, Dicpinigaitis AJ, Negassa A. Effect of e-Cigarette Use on Cough Reflex Sensitivity. Chest. 2016 Jan;149(1):161-5. doi: 10.1378/chest.15-0817. Epub 2016 Jan 6.
- Individual participant dataSharing planned: No. Results of this study have been published in January 2016 as a full manuscript.
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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.
Peter V Dicpinigaitis, MD principal investigator
Montefiore Medical Center and Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing electronic cigarette exposure in people with Cough, run by Montefiore Medical Center at 1 site in United States.
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 2 inclusion and 3 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 28 Jun 2023. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Cough Reflex Sensitivity (Log C5) (time frame: Baseline, 15 minutes, and 24 hours post-exposure to e-cig.). 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 NCT02203162, 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 28 Jun 2023; AzTrials last refreshed its copy on 2 Nov 2026.