Inflammatory ResponseNCT04864600
CANDLE - A Study of Acute Health Effects of Exposure to Particles Generated by Candles
A study testing Candle C and Candle 1 in people with Inflammatory Response and Symptoms and Signs, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Inflammatory Response, Symptoms and Signs
- What is being tested?
- Candle C and Candle 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Climate Chambers, Dept. Public Health, Aarhus University
Aarhus, Central Region Denmark, 8000
About this study
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.
Read the 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
- Being tested
- Candle C, Candle 1
- Keywords
- Stearin candle, Health effects, Inflammation, Asthmatics, Particle contamination, Indoor air, Pollutant
- Medical subject headings
- Signs and Symptoms, Inflammation, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candle COther
Burning candles will produce particulate air pollution being passed on an exposure chamber where the participants will be sitting for 5 hours.
Candle 1Other
Burning candles will produce particulate air pollution being passed on an exposure chamber where the participants will be sitting for 5 hours.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Candle C |
| Clean Air | No intervention | No candles in the chamber. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
Secondary outcomes (12)
Change in Lung Function (FEV1 & FVC)
Spirometry
Measured: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
Change in Fractional exhaled nitric oxide (FENO)
NIOX VERO system; Aerocrine AB, Sweden
Measured: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
Change in white blood cells in Blood
White blood cells
Measured: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
Change in Endothelial Progenitor Cells (EPCs) in Blood
Endothelial progenitor cells (EPC) further divided into early and late EPCs
Measured: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
Change in inflammatory markers in Blood
Interleukin 8, interleukin 1
Measured: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
Change in biomarkers in Blood
Metabolomics
Measured: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
Change in nasal volume (using Acoustic rhinometry)
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 is 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 is determined on both sides.
Measured: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
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. (same unit measure))
Measured: after exposure (5 hours), and the day after exposure (24 hours)
ReCIVA
Sampling of VOCs and particles in exhaled air. Breathing through a mask for 10-15 minutes makes it possible to collect VOCs and particles into tenax air sampling tubes.
Measured: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
Change in Subjective Symptoms
n the exposure chamber participants are asked to fill out a symptom questionnaire every 30 minute regarding their well-being and experienced symptoms in eyes, nose and throat. The participants are asked to score their evaluation / rate the strength of symptoms on a Linear Numeric Scale from 0-10, with 10 being worst. Health effects are evaluated in relation to rated changes in symptoms
Measured: Every 30 minute during 5 hours of exposure
Heart rate using a Fitbit
Using a Fitbit watch participants' heart rate is measured.
Measured: From exposure start until the morning after exposure (in total 24 hours)
Sleep quality using a Fitbit
Using a Fitbit watch participants' sleep quality is measured.
Measured: during 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start1 Sep 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory ResponseStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, University of Copenhagen, Danish Technological Institute, ASP-HOLMBLAD A/S, COOP Denmark, Danwax, Liljeholmens Stearinfabrik, Promol, European Candle Association
- Responsible party
- Principal investigator, Torben Sigsgaard, University of Aarhus
- Investigators
- Torben Sigsgaard, Prof., Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864600
- Sponsor's protocol ID
- 201100
- Status last verified
- Apr 2021
- First submitted
- 4 Nov 2020
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CANDLE - A Study of Acute Health Effects of Exposure to Particles Generated by Candles
- ClinicalTrials.gov ID
- NCT04864600
- Acronym / sponsor ID
- 201100
- Conditions
- Inflammatory Response, Symptoms and Signs
- Keywords
- Stearin candle, Health effects, Inflammation, Asthmatics, Particle contamination, Indoor air, Pollutant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Lund University, University of Copenhagen, Danish Technological Institute, ASP-HOLMBLAD A/S, COOP Denmark, Danwax, Liljeholmens Stearinfabrik, Promol, European Candle Association
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Standard Stearin Candle | Active comparator | Other: Candle 1Several candles will be lit. We will be using realistic burning cycles i.e. burning candles which extinguish and new ones being lit. |
| Modified low emission candle | Experimental | Other: Candle CSeveral candles will be lit. We will be using realistic burning cycles i.e. burning candles which extinguish and new ones being lit. |
| Clean Air | No intervention | –No candles in the chamber. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Candle CBurning candles will produce particulate air pollution being passed on an exposure chamber where the participants will be sitting for 5 hours. | Other | Modified low emission candle |
| Candle 1Burning candles will produce particulate air pollution being passed on an exposure chamber where the participants will be sitting for 5 hours. | Other | Standard Stearin Candle |
Primary outcome
Change in Particles in Exhaled Air (Surfactant Protein A & Albumin)
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 PExA® instrument set-up
12 secondary outcomes
Change in Lung Function (FEV1 & FVC)
Time frame: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
Change in Fractional exhaled nitric oxide (FENO)
Time frame: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
Change in white blood cells in Blood
Time frame: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
Change in Endothelial Progenitor Cells (EPCs) in Blood
Time frame: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
Change in inflammatory markers in Blood
Time frame: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
Change in biomarkers in Blood
Time frame: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
Change in nasal volume (using Acoustic rhinometry)
Time frame: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
Change in biomarkers in Saliva Sample
Time frame: after exposure (5 hours), and the day after exposure (24 hours)
ReCIVA
Time frame: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
Change in Subjective Symptoms
Time frame: Every 30 minute during 5 hours of exposure
Heart rate using a Fitbit
Time frame: From exposure start until the morning after exposure (in total 24 hours)
Sleep quality using a Fitbit
Time frame: during 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torben Sigsgaard, Prof. principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Candle C and Candle 1 in people with Inflammatory Response and Symptoms and Signs, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Particles in Exhaled Air (Surfactant Protein A & Albumin) (time frame: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.