跳至主要内容
临床试验/NCT04315740
NCT04315740已完成不适用

THE ULTRAFINE PROJECT - A Study of Acute Health Effects of Exposure to Particles Generated by Candles and Cooking

University of Aarhus2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
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

People spend up to 90% of their life indoor, and the way we live and behave in our homes has substantial effects on our health and well-being. Particle contamination is suggested to have substantial negative effects on health, with candles and cooking emitting the largest amount of particles, thus being the largest contributors to indoor air pollution.

The overall aim of the present project is to contribute to increased understanding of the association between indoor particulate air pollution and health and well-being.

详细描述

Introduction

People spend up to 90% of their life indoor, and the way we live and behave in our homes has substantial effects on our health and well-being. Particle contamination is suggested to have substantial negative effects on health, with candles and cooking emitting the largest amount of particles, thus being the largest contributors to indoor air pollution. Little is known about the potential adverse health effects of candles and cooking, and people with asthma may be more susceptible.

Aim: To investigate local and systemic effects of short-term exposure to lit candles and cooking among young asthmatics.

Design: In a randomised double-blinded cross-over study non-smoking asthmatics (18-25 years) were exposed for five hours at three different exposure conditions separated by 14 days; A) clean filtered air, B) lit candles and C) cooking emissions 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

The exposure was generated in small adjacent chamber and thereby led into the exposure chamber using a pipe connection and a small negative pressure. Thus, the exposure could not be observed.

入排标准

年龄范围
15 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 15-25
  • Medically treated / physician diagnosed mild seasonal asthma
  • 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: Time Frame: 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 (novel) PExA® instrument set-up.

次要结局

  • 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 nasal volume (using Acoustic rhinometry)(At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours))
  • Change in Blood samples(At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours))
  • Change in biomarkers in Saliva Sample(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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Torben Sigsgaard

Professor

University of Aarhus

研究点 (2)

Loading locations...

相似试验