E Cig UseNCT04395274

Young Adult EC Use and Respiratory Outcomes

An observational study of E Cig Use, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 25 yearsHealthy volunteers can take part
Conditions the study is for: E Cig Use
How many people: 115 participants
Where: 1 siteUnited States
Study dates: 15 Dec 2021to 21 Feb 2024
Phase: Observational
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 to 25 years
All sexes
Healthy volunteers accepted
Adult

Study population: The present proposal, a study of e-cigarette use among youth and young adults, will include both females and racial/ethnic minorities.

Who may be able to join

own a smartphone and willing to add study EMA and spirometry application to it.
a current exclusive-EC user (endorse ≥weekly use over the past 3 months) and report never trying OTPs
between the ages of 18-25 years old at the time of enrollment
read and speak English
willing to complete five, 2-week periods of daily EMA and home-based spirometry
never-users must indicate never trying any tobacco product to be eligible for enrollment

Who cannot join

self-reported diagnosis of lung disease including cystic fibrosis or chronic obstructive pulmonary disease; we will not exclude youth who have asthma, but will incorporate this as a covariate during analyses
unstable or significant psychiatric conditions (past and stable conditions will be allowed)
history of cardiac event or distress within the past 3 months
are currently pregnant, planning to become pregnant, or breastfeeding
are blind, severely visually impaired, deaf, hard of hearing, or have a severe motor disability

Trial locations and contacts

1 site in 1 country.

United States1 site

The Ohio State University
Columbus, Ohio, 43214

Other trials in United States

About this study

E-cigarette (EC) use continues to increase among youth, and EC may be detrimental to youth respiratory health. Public health officials and the Food and Drug Administration (FDA) can now regulate ECs. The proposed study uses naturalistic assessments called ecological momentary assessment (EMA) to understand how ECs use may impact the respiratory health of youth and young adult users compared to never-using peers.

Read the detailed description

Using a prospective longitudinal design, 150 youth and young adults aged 18-25 years (100 exclusive-EC users; 50 never-users) will complete 5 sessions (baseline, 3-,6-, 9-, and 12-months). Sessions will include naturalistic measures such as measures of respiratory health, questionnaires, and nasal epithelial lining fluid (NELF) nasal samples. To assess acute changes in pulmonary functioning related to tobacco product use, participants will complete twice daily EMA and home-based spirometry for the 2 weeks following the Day 1 session and the 2 weeks prior to each follow-up zoom session. Never-users will participate in a brief 15-30-minute individual interview consisting of questions related to reasons for never-EC use and other protective factors that will be used to build future prevention messaging.

Conditions: E Cig Use
Keywords: e-cigarette, respiratory health, prospective
Medical subject headings: Vaping

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04395274
Study group	Role	What they receive
Current E-Cigarette Users		Monitoring current e-cigarette users
Never E-Cigarette / Tobacco Users		Monitoring never users of any tobacco or e-cigarette products.

What is being measured

The primary outcome is the main question the study is designed to answer.

Spirometry to Measure the Change From Baseline in Forced Vital Capacity (FVC)
Participants will complete twice daily home-based spirometry (a pulmonary function diagnostic test) for the 2 weeks prior to each follow-up session.
Measured: Baseline, 3-month, 6-month, 9-month, 12-month
Spirometry to Measure the Change From Baseline in Forced Expiratory Volume (FEV)
Participants will complete twice daily home-based spirometry (a pulmonary function diagnostic test) for the 2 weeks prior to each follow-up session.
Measured: Baseline, 3-month, 6-month, 9-month, 12-month
Level of Dependence by Product Type Will be Examined.
Changes in product use evaluated with an evaluation of the changes in dependence using the Hooked on Nicotine Checklist (HONC).
Scores range from 0 to 10 with higher values indicating greater levels of dependence.
Measured: Baseline, 3-month, 6-month, 9-month, 12-month
Respiratory Health Measures by Nasal Swab - IL-6
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine).
Measured: Baseline, 3-month, 6-month, 9-month, 12-month
Respiratory Health Measures by Nasal Swab - IL-8
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Measured: Baseline, 3-month, 6-month, 9-month, 12-month
Respiratory Health Measures by Nasal Swab - TNF-alpha
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Measured: Baseline, 3-month, 6-month, 9-month, 12-month
Respiratory Health Measures by Nasal Swab - IL-4
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Measured: Baseline, 3-month, 6-month, 9-month, 12-month
Respiratory Health Measures by Nasal Swab - IL-5
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Measured: Baseline, 3-month, 6-month, 9-month, 12-month
Respiratory Health Measures by Nasal Swab - IL-10
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Measured: Baseline, 3-month, 6-month, 9-month, 12-month
Respiratory Health Measures by Nasal Swab - IL-13
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Measured: Baseline, 3-month, 6-month, 9-month, 12-month
Respiratory Health Measures by Nasal Swab - TARC
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Measured: Baseline, 3-month, 6-month, 9-month, 12-month
Respiratory Health Measures by Nasal Swab - Eotaxin
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Measured: Baseline, 3-month, 6-month, 9-month, 12-month
Respiratory Health Measures by Nasal Swab - MCP-1
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Measured: Baseline, 3-month, 6-month, 9-month, 12-month
Respiratory Health Measures by Nasal Swab - MCP-4
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Measured: Baseline, 3-month, 6-month, 9-month, 12-month
Respiratory Health Measures by Nasal Swab - Cotinine
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Measured: Baseline, 3-month, 6-month, 9-month, 12-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Dec 202121 Feb 2024

First posted20 May 2020
Study start15 Dec 2021
Primary completion21 Feb 2024
Study completion21 Feb 2024

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.
Other trials for E Cig UseStudies of the same condition, open and under way.
More trials run by Ohio State University Comprehensive Cancer 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 115 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04395274
Sponsor's protocol ID: OSU-23006
Other IDs: 1K01HL148907-01, NCI-2024-06207
Status last verified: Nov 2024
First submitted: 21 Apr 2020
Last updated: 12 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
PK/PD of Vaping THC-containing Liquids vs. Smoked Cannabis
Cigarette Smoking-Related Carcinoma
Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Active, not recruiting
Mindful Breaths: Mindfulness for Young Adult Vaping
Vaping Cessation
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence

All E Cig Use trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Young Adult EC Use and Respiratory Outcomes
ClinicalTrials.gov ID: NCT04395274
Acronym / sponsor ID: OSU-23006
Conditions: E Cig Use
Keywords: e-cigarette, respiratory health, prospective
Study type: Observational
Recruitment status: Completed
Enrolment: 115 participants (actual)
Lead sponsor: Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Food and Drug Administration (FDA)
Study start: 15 Dec 2021 (actual)
Primary completion: 21 Feb 2024 (actual)
Study completion: 21 Feb 2024 (actual)
First posted: 20 May 2020 (actual)
Results: Posted 12 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Current E-Cigarette Users	–	–Monitoring current e-cigarette users
Never E-Cigarette / Tobacco Users	–	–Monitoring never users of any tobacco or e-cigarette products.

Who may qualify

Ages: 18 to 25 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult
Study population: The present proposal, a study of e-cigarette use among youth and young adults, will include both females and racial/ethnic minorities.

Key inclusion criteria (6 listed)

own a smartphone and willing to add study EMA and spirometry application to it.
a current exclusive-EC user (endorse ≥weekly use over the past 3 months) and report never trying OTPs
between the ages of 18-25 years old at the time of enrollment
read and speak English
willing to complete five, 2-week periods of daily EMA and home-based spirometry

Key exclusion criteria (5 listed)

self-reported diagnosis of lung disease including cystic fibrosis or chronic obstructive pulmonary disease; we will not exclude youth who have asthma, but will incorporate this as a covariate during analyses
unstable or significant psychiatric conditions (past and stable conditions will be allowed)
history of cardiac event or distress within the past 3 months
are currently pregnant, planning to become pregnant, or breastfeeding
are blind, severely visually impaired, deaf, hard of hearing, or have a severe motor disability

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

Spirometry to Measure the Change From Baseline in Forced Vital Capacity (FVC)
Time frame: Baseline, 3-month, 6-month, 9-month, 12-month
Participants will complete twice daily home-based spirometry (a pulmonary function diagnostic test) for the 2 weeks prior to each follow-up session.
Spirometry to Measure the Change From Baseline in Forced Expiratory Volume (FEV)
Time frame: Baseline, 3-month, 6-month, 9-month, 12-month
Participants will complete twice daily home-based spirometry (a pulmonary function diagnostic test) for the 2 weeks prior to each follow-up session.
Level of Dependence by Product Type Will be Examined.
Time frame: Baseline, 3-month, 6-month, 9-month, 12-month
Changes in product use evaluated with an evaluation of the changes in dependence using the Hooked on Nicotine Checklist (HONC). Scores range from 0 to 10 with higher values indicating greater levels of dependence.
Respiratory Health Measures by Nasal Swab - IL-6
Time frame: Baseline, 3-month, 6-month, 9-month, 12-month
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine).
Respiratory Health Measures by Nasal Swab - IL-8
Time frame: Baseline, 3-month, 6-month, 9-month, 12-month
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Respiratory Health Measures by Nasal Swab - TNF-alpha
Time frame: Baseline, 3-month, 6-month, 9-month, 12-month
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Respiratory Health Measures by Nasal Swab - IL-4
Time frame: Baseline, 3-month, 6-month, 9-month, 12-month
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Respiratory Health Measures by Nasal Swab - IL-5
Time frame: Baseline, 3-month, 6-month, 9-month, 12-month
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Respiratory Health Measures by Nasal Swab - IL-10
Time frame: Baseline, 3-month, 6-month, 9-month, 12-month
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Respiratory Health Measures by Nasal Swab - IL-13
Time frame: Baseline, 3-month, 6-month, 9-month, 12-month
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Respiratory Health Measures by Nasal Swab - TARC
Time frame: Baseline, 3-month, 6-month, 9-month, 12-month
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Respiratory Health Measures by Nasal Swab - Eotaxin
Time frame: Baseline, 3-month, 6-month, 9-month, 12-month
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Respiratory Health Measures by Nasal Swab - MCP-1
Time frame: Baseline, 3-month, 6-month, 9-month, 12-month
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Respiratory Health Measures by Nasal Swab - MCP-4
Time frame: Baseline, 3-month, 6-month, 9-month, 12-month
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.
Respiratory Health Measures by Nasal Swab - Cotinine
Time frame: Baseline, 3-month, 6-month, 9-month, 12-month
Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use.

Results and safety

Results posted to the registry on 12 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Current E-Cigarette Users	52	19
Never E-Cigarette / Tobacco Users	53	31

Primary outcome: Spirometry to Measure the Change From Baseline in Forced Vital Capacity (FVC)

Time frame: Baseline, 3-month, 6-month, 9-month, 12-month. Mean (Standard Deviation). Unit: liter

Measure	Current E-Cigarette Users n = 43	Never E-Cigarette / Tobacco Users n = 49
Baseline	4.42 (1.30)	3.54 (0.97)
3-month	4.61 (1.70)	3.68 (1.00)
6-month	4.62 (1.66)	3.96 (1.10)
9-month	4.52 (1.26)	3.89 (1.09)
12-month	4.34 (1.45)	4.33 (1.00)

Population analysed: Only participants who were eligible at baseline and provided spirometry measurements are included. The number of participants at follow-up is less than that at baseline due to loss to follow-up over time.

Primary outcome: Spirometry to Measure the Change From Baseline in Forced Expiratory Volume (FEV)

Time frame: Baseline, 3-month, 6-month, 9-month, 12-month. Mean (Standard Deviation). Unit: Liters

Measure	Current E-Cigarette Users n = 43	Never E-Cigarette / Tobacco Users n = 49
Baseline	3.63 (0.93)	3.04 (0.70)
3-month	3.64 (1.12)	3.18 (0.72)
6-month	3.67 (1.15)	3.36 (0.83)
9-month	3.81 (0.85)	3.34 (0.84)
12-month	3.60 (0.96)	3.63 (0.82)

Primary outcome: Level of Dependence by Product Type Will be Examined.

Time frame: Baseline, 3-month, 6-month, 9-month, 12-month. Mean (Standard Deviation). Unit: score on a scale

Measure	Disposable Users n = 24	Pod Mod Users n = 20	Other Device Type Users n = 6
Baseline	5.83 (3.06)	7.35 (2.83)	7.67 (2.34)
3-month	5.55 (3.36)	8.44 (1.01)	7.00 (1.41)
6-month	6.30 (3.71)	8.50 (1.38)	–
9-month	5.86 (3.08)	8.33 (0.58)	–
12-month	6.71 (3.35)	7.40 (0.89)	–

Population analysed: Only participants who were eligible and using e-cigarettes at baseline are included. The number of participants at follow-up is less than that at baseline due to loss to follow-up over time.

Primary outcome: Respiratory Health Measures by Nasal Swab - IL-6

Time frame: Baseline, 3-month, 6-month, 9-month, 12-month. Mean (Standard Deviation). Unit: pg/mL

Measure	Current E-Cigarette Users n = 42	Never E-Cigarette / Tobacco Users n = 49
Baseline	14.31 (24.97)	9.95 (19.57)
3-month	49.50 (113.35)	17.63 (35.50)
6-month	19.72 (30.59)	37.01 (91.92)
9-month	14.83 (27.87)	12.63 (25.82)
12-month	11.16 (19.36)	48.85 (141.49)

Population analysed: The population of participants who both attended their study visit and were able to provide a NELF sample is analyzed. Note that not all participants provided a sample at all visits.

Adverse events

Time frame: 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Current E-Cigarette Users	0 of 52 (0%)	11 of 52 (21.2%)	0 of 52
Never E-Cigarette / Tobacco Users	0 of 53 (0%)	0 of 53 (0%)	0 of 53

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
The JameslineLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for E Cig Use

Not yet recruitingPhase 1
PK/PD of Vaping THC-containing Liquids vs. Smoked Cannabis
Cigarette Smoking-Related Carcinoma
Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Active, not recruiting
Mindful Breaths: Mindfulness for Young Adult Vaping
Vaping Cessation
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence

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.

Alayna Tackett, PhD principal investigator

The Ohio State Comprehensive Cancer Center

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 Cig Use, run by Ohio State University Comprehensive Cancer 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 6 inclusion and 5 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 12 Dec 2024. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2024). 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?

Spirometry to Measure the Change From Baseline in Forced Vital Capacity (FVC) (time frame: Baseline, 3-month, 6-month, 9-month, 12-month). The study lists 15 primary outcomes in all. 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 NCT04395274.

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 12 Dec 2024.