N/A
N=105
Young Adult EC Use and Respiratory Outcomes
E Cig Use
Bottom Line
View on ClinicalTrials.gov: NCT04395274 ↗Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Spirometry to Measure the Change From Baseline in Forced Vital Capacity (FVC) — 4.42; 3.54; 4.61; 3.68 liter
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Spirometry to Measure the Change From Baseline in Forced Vital Capacity (FVC) |
4.42; 3.54; 4.61; 3.68; 4.62; 3.96 | — |
| PRIMARY Spirometry to Measure the Change From Baseline in Forced Expiratory Volume (FEV) |
3.63; 3.04; 3.64; 3.18; 3.67; 3.36 | — |
| PRIMARY Level of Dependence by Product Type Will be Examined. |
5.83; 7.35; 7.67; 5.55; 8.44; 7.00 | — |
| PRIMARY Respiratory Health Measures by Nasal Swab - IL-6 |
14.31; 9.95; 49.50; 17.63; 19.72; 37.01 | — |
| PRIMARY Respiratory Health Measures by Nasal Swab - IL-8 |
6637.06; 12872.08; 7630.32; 13890.15; 9509.56; 20161.25 | — |
| PRIMARY Respiratory Health Measures by Nasal Swab - TNF-alpha |
5.86; 4.98; 11.14; 7.15; 6.53; 6.25 | — |
| PRIMARY Respiratory Health Measures by Nasal Swab - IL-4 |
0.46; 0.12; 0.34; 0.38; 0.12; 0.23 | — |
| PRIMARY Respiratory Health Measures by Nasal Swab - IL-5 |
7.45; 0.64; 8.10; 0.58; 2.40; 1.79 | — |
| PRIMARY Respiratory Health Measures by Nasal Swab - IL-10 |
3.17; 0.75; 16.73; 1.41; 2.10; 46.13 | — |
| PRIMARY Respiratory Health Measures by Nasal Swab - IL-13 |
14.68; 13.13; 16.94; 16.02; 14.02; 14.28 | — |
| PRIMARY Respiratory Health Measures by Nasal Swab - TARC |
8.97; 26.73; 16.88; 41.36; 19.28; 26.22 | — |
| PRIMARY Respiratory Health Measures by Nasal Swab - Eotaxin |
135.72; 167.33; 135.21; 208.15; 228.79; 188.60 | — |
| PRIMARY Respiratory Health Measures by Nasal Swab - MCP-1 |
198.65; 228.50; 247.34; 387.24; 316.92; 289.26 | — |
| PRIMARY Respiratory Health Measures by Nasal Swab - MCP-4 |
6.88; 6.94; 5.94; 7.79; 16.62; 8.74 | — |
| PRIMARY Respiratory Health Measures by Nasal Swab - Cotinine |
156.56; 0.09; 145.43; 0.08; 146.15; 0.09 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04395274). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.