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

NCT04864600 | Completed DMC

• 1 other identifier: 201100
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Response; Symptoms and Signs

Keywords

Stearin candle; Health effects; Inflammation; Asthmatics; Particle contamination; Indoor air; Pollutant

Outcome Measures

Primary Outcomes (1)

• 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 PExA® instrument set-up

  At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)

Secondary Outcomes (12)

• 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 white blood cells in Blood

  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)

Study Arms (3)

Standard Stearin Candle

ACTIVE COMPARATOR

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

Other: Candle 1

Modified low emission candle

EXPERIMENTAL

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

Other: Candle C

Clean Air

NO INTERVENTION

No candles in the chamber.

Interventions

Candle C 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

Candle 1 OTHER

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

Standard Stearin Candle

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Lund University: collaborator
• University of Copenhagen: collaborator
• Danish Technological Institute: collaborator
• ASP-HOLMBLAD A/S: collaborator
• COOP Denmark: collaborator
• Danwax: collaborator
• Liljeholmens Stearinfabrik: collaborator
• Promol: collaborator
• European Candle Association: collaborator

Study Sites (1)

Climate Chambers, Dept. Public Health, Aarhus University

Aarhus, Central Region Denmark, 8000, Denmark

Location

MeSH Terms

Conditions

Signs and Symptoms; Inflammation; Asthma

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Pathologic Processes; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Torben Sigsgaard, Prof.

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and medical doctor

Model Details: A randomized cross-over double-blind study under controlled conditions in a climate chamber having three different exposures; A) a standard (Scandinavian) stearin candle, B) a modified low emitting version of the same candle, and C) clean air

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: April 29, 2021
• Study Start: September 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)