CANDLE - A Study of Acute Health Effects of Exposure to Particles Generated by Candles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 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
INTRODUCTION: Particle contamination is suggested to have substantial negative effects on health, with candles emitting huge amount of particles, thus being one of the largest contributors to indoor air pollution. Chronic low levels of exposure to indoor particles over time is an important risk factor for the health of the population as a whole and it becomes particularly important for vulnerable groups like people suffering from respiratory diseases such as asthma.
AIM: In a randomized controlled cross-over trial the difference in health effects between two candles I) a standard candle and II) a low emission candle modified from the standard candle is studied.
详细描述
INTRODUCTION; Particle contamination is suggested to have substantial negative effects on health, with candles emitting the huge amount of particles, thus being one of the largest contributors to indoor air pollution. Chronic low levels of exposure to indoor particles over time is an important risk factor for the health of the population as a whole and it becomes particularly important for vulnerable groups like children and the elderly or people already suffering from allergies and respiratory diseases such as asthma.
AIM: To study the difference in health effects between two candles I) a standard candle and II) a low emission candle modified from the standard candle. The following hypothesis will be examined: Short-term exposure to particles generated by the standard candle is associated with more objectively measurable effects in metabolomics inflammation compared to exposure to modified low-emission candle particles.
METHODS: Separated by two weeks 20 young asthmatics will be exposed in a randomized cross-over double-blind study under controlled conditions in a climate chamber to three different exposures; A) a standard (Scandinavian) stearin candle, B) a modified low emitting version of the same candle, and C) clean air from the adjacent chamber. The experiment will be carried out in groups of 3-6 participants.
MEASUREMENTS: TSI P-TRAK Ultrafine Particle Counter and SMPS will be used for particle counts. Health effects, including spirometry and fraction of exhaled nitric oxide (FeNO) will be 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-25
- •Medically treated / physician diagnosed mild seasonal asthma GINA guidelines step 1 or 2 (https://ginasthma.org/)
- •Never smoker or ex-smoker ≥ 6 months
- •Allergy > 1 common allergy
排除标准
- •Any other disease that could influence the study parameters
- •Conditions that prevent safe access to the climate chambers (such as claustrophobia)
- •Perennial asthma
- •Need for continuous medical treatment for asthma
- •Pregnancy
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 (5 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 PExA® instrument set-up
次要结局
- Change in white blood cells in Blood(At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours))
- Heart rate using a Fitbit(From exposure start until the morning after exposure (in total 24 hours))
- Change in Lung Function (FEV1 & FVC)(At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours))
- Change in Fractional exhaled nitric oxide (FENO)(At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours))
- Change in Endothelial Progenitor Cells (EPCs) in Blood(At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours))
- Change in inflammatory markers in Blood(At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours))
- Change in biomarkers in Blood(At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours))
- Change in nasal volume (using Acoustic rhinometry)(At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours))
- Change in biomarkers in Saliva Sample(after exposure (5 hours), and the day after exposure (24 hours))
- ReCIVA(At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours))
- Change in Subjective Symptoms(Every 30 minute during 5 hours of exposure)
- Sleep quality using a Fitbit(during 48 hours)
研究者
Torben Sigsgaard
Professor and medical doctor
University of Aarhus