CANDLE - A Study of Acute Health Effects of Exposure to Particles Generated by Candles

NCT ID: NCT04864600

Last Updated: 2021-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2020-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Inflammatory Response; Symptoms and Signs

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Standard Stearin Candle

Several candles will be lit. We will be using realistic burning cycles i.e. burning candles which extinguish and new ones being lit.

Group Type: ACTIVE_COMPARATOR

Candle 1

Intervention Type: OTHER

Burning candles will produce particulate air pollution being passed on an exposure chamber where the participants will be sitting for 5 hours.

Modified low emission candle

Several candles will be lit. We will be using realistic burning cycles i.e. burning candles which extinguish and new ones being lit.

Group Type: EXPERIMENTAL

Candle C

Intervention Type: OTHER

Burning candles will produce particulate air pollution being passed on an exposure chamber where the participants will be sitting for 5 hours.

Clean Air

No candles in the chamber.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Candle C

Burning candles will produce particulate air pollution being passed on an exposure chamber where the participants will be sitting for 5 hours.

Intervention Type: OTHER

Candle 1

Burning candles will produce particulate air pollution being passed on an exposure chamber where the participants will be sitting for 5 hours.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: collaborator

Danish Technological Institute

UNKNOWN

Sponsor Role: collaborator

ASP-HOLMBLAD A/S

UNKNOWN

Sponsor Role: collaborator

COOP Denmark

UNKNOWN

Sponsor Role: collaborator

Danwax

UNKNOWN

Sponsor Role: collaborator

Liljeholmens Stearinfabrik

UNKNOWN

Sponsor Role: collaborator

Promol

UNKNOWN

Sponsor Role: collaborator

European Candle Association

UNKNOWN

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Torben Sigsgaard

Professor and medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Torben Sigsgaard, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

Climate Chambers, Dept. Public Health, Aarhus University

Aarhus, Central Region Denmark, Denmark

Countries

Denmark

Other Identifiers

201100

Identifier Type: -

Identifier Source: org_study_id