Acute Health Effects Due to Ultrafine Particles From Candles and Cooking

Asthma Clinical Trial

— Ultrafine  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04315740
• Other study ID #: 191100
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: December 20, 2019

Study information

• Verified date: March 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Candle Burning
• Cooking
• DNA Damage
• Lung Function Decreased
• Subjective Health

Intervention

Other:
• Particles from candles
Generating fine and ultrafine particles from lit candles
• Particles from cooking
Generating fine and ultrafine particles from frying pork in an oven
• Clean Air
Nothing but clean air

Locations

Country	Name	City	State
Denmark	Climate Chambers, Dept. Public Health, Aarhus University	Aarhus	Central Region Denmark

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

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.	Time Frame: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
Secondary	Change in Lung Function (FEV1 & FVC)	Spirometry	At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
Secondary	Change in Fractional exhaled nitric oxide (FENO)	NIOX VERO system; Aerocrine AB, Sweden	At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
Secondary	Change in Blood samples	Cytokines (IL-8), DNA-damages	At baseline (0 hour), after exposure (5 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 (5 hours), and the day after exposure (24 hours)
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 (5 hours), and the day after exposure (24 hours)
Secondary	Change in Subjective Symptoms	In the exposure chamber participants were asked to fill out a symptom questionnaire every 30 minute regarding their well-being and experienced symptoms in eyes, nose and throat. The participants were asked to score their evaluation (rate the strength) of symptoms by placing a cross on a 130 mm open Visual Analogue Scale (VAS). The intensity of any discomfort was registered as the length in mm from the left of the scale to the marker. The scores were rated from 0 to 100% with highest number corresponding to highest discomfort. Health effects were evaluated in relation to rated changes in symptoms.	Every 30 minute during 5 hours of exposure