Acute Health Effects of Passive Exposure to Particles From Electronic Cigarettes - a Randomized Controlled Double-blinded Cross-over Trial Among COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in Particles in Exhaled Air (Surfactant Protein A & Albumin)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Vaping was done in another chamber and thereby led into the exposure chamber, so it could not be observed. On days with clean air, vapers were chewing nicotine gum instead of vaping.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Never smoker or ex-smokers ≥ 6 months
- •A known diagnosis of COPD (FEV1/FVC < lower limit of normal, app. 70%)
- •MRC ≥ 2 or CAT score ≥ 10
排除标准
- •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
结局指标
主要结局
Change in Particles in Exhaled Air (Surfactant Protein A & Albumin)
时间窗: 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.
次要结局
- Change in Fractional exhaled nitric oxide (FENO)(At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours))
- Change in Lung Function (FEV1 & FVC)(At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours))
- Change in Blood samples(At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours))
- Change in nasal volume (using Acoustic rhinometry)(At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours))
- Change in Symptom questionnaire(Every 30 min during 4 hours of exposure.)
- Change in biomarkers in Saliva Sample(At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours))
研究者
Torben Sigsgaard
Professor, Doctor
University of Aarhus