Clinical trial NCT04315740: Acute Health Effects Due to Ultrafine Particles From Candles and Cooking
Official title: THE ULTRAFINE PROJECT - A Study of Acute Health Effects of Exposure to Particles Generated by Candles and Cooking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Candle Burning
Cooking
Lung Function Decreased
DNA Damage
Subjective Health
Asthma
Keywords: Particle contamination
Indoor air
Acute health effects
RCT
Asthma
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Aarhus University Hospital
First posted: 2020-03-19
Enrollment: 36
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomised double-blinded crossover study
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Aged 15-25
* Medically treated / physician diagnosed mild seasonal asthma
* Never smoker or ex-smoker ≥ 6 months
* Allergy \> 1 common allergy

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Particles in Exhaled Air (Surfactant Protein A & Albumin)
timeFrame: Time Frame: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
Secondary outcomes:
measure: Change in Lung Function (FEV1 & FVC)
timeFrame: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
measure: Change in Fractional exhaled nitric oxide (FENO)
timeFrame: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
measure: Change in Blood samples
timeFrame: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
measure: Change in nasal volume (using Acoustic rhinometry)
timeFrame: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
measure: Change in biomarkers in Saliva Sample
timeFrame: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
measure: Change in Subjective Symptoms
timeFrame: Every 30 minute during 5 hours of exposure
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Climate Chambers, Dept. Public Health, Aarhus University
state: Central Region Denmark
Study officials:
affiliation: Department of Public Health, Aarhus Universitet
name: Karin R Laursen, MSc
role: PRINCIPAL_INVESTIGATOR
References: