Electronic Cigarette Use Clinical Trial
— PASVAPOfficial title:
Acute Health Effects of Passive Exposure to Particles From Electronic Cigarettes - a Randomized Controlled Double-blinded Cross-over Trial Among COPD Patients
NCT number | NCT04316234 |
Other study ID # | 1711000 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2017 |
Est. completion date | November 30, 2017 |
Verified date | March 2020 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | November 30, 2017 |
Est. primary completion date | November 30, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University | Aarhus | Central Region Denmark |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Aarhus University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours) | |
Secondary | Change in Lung Function (FEV1 & FVC) | Spirometry | At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours) | |
Secondary | Change in Fractional exhaled nitric oxide (FENO) | NIOX system; Aerocrine AB, Sweden | At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours) | |
Secondary | Change in Blood samples | IL-8, Nightingale analyses for biomarkers | At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours) | |
Secondary | 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. | At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours) | |
Secondary | 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. | Every 30 min during 4 hours of exposure. | |
Secondary | 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.) | At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours) |
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