Candle BurningUltrafineNCT04315740
Acute Health Effects Due to Ultrafine Particles From Candles and Cooking
A study testing Particles from candles, Particles from cooking and Clean Air in people with Candle Burning and Cooking, run by University of Aarhus at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 15 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Candle Burning, Cooking, Lung Function Decreased
- What is being tested?
- Particles from candles, Particles from cooking and Clean Air
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2019to 20 Dec 2019
- 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 15 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged 15-25
- Medically treated / physician diagnosed mild seasonal asthma
- 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
Official title: THE ULTRAFINE PROJECT - A Study of Acute Health Effects of Exposure to Particles Generated by Candles and Cooking
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.
Read the 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.
- Conditions
- Candle Burning, Cooking, Lung Function Decreased, DNA Damage, Subjective Health, Asthma
- Being tested
- Particles from candles, Particles from cooking, Clean Air
- Keywords
- Particle contamination, Indoor air, Acute health effects, RCT, Asthma
- Medical subject headings
- Respiratory Insufficiency, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Particles from candlesOther
Generating fine and ultrafine particles from lit candles
Particles from cookingOther
Generating fine and ultrafine particles from frying pork in an oven
Clean AirOther
Nothing but clean air
| Study group | Role | What they receive |
|---|---|---|
| Clean Air | Sham comparator | Just clean air - no exposure Receives: Other: Clean Air |
| Cooking | Experimental | Four ovens were frying pork - one at a time. When the first oven finished, the next oven started and so forth for approx. 7 hours. Receives: Other: Particles from cooking |
| Candles | Experimental | 10 lit candles were placed at a table. Burning for approx. 7 hours with light ventilation. Receives: Other: Particles from candles |
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 (novel) PExA® instrument set-up.
Measured: Time Frame: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
Secondary outcomes (6)
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 Blood samples
Cytokines (IL-8), DNA-damages
Measured: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
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.
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.)
Measured: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)
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.
Measured: Every 30 minute during 5 hours of exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start1 Apr 2019
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candle BurningStudies 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 randomised double-blinded crossover study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Aarhus University Hospital
- Responsible party
- Principal investigator, Torben Sigsgaard, University of Aarhus
- Investigators
- Karin R Laursen, MSc, Principal investigator, Department of Public Health, Aarhus Universitet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315740
- Sponsor's protocol ID
- 191100
- Acronym
- Ultrafine
- Status last verified
- Mar 2020
- First submitted
- 18 Mar 2020
- Last updated
- 6 Nov 2020
- 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 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE ULTRAFINE PROJECT - A Study of Acute Health Effects of Exposure to Particles Generated by Candles and Cooking
- ClinicalTrials.gov ID
- NCT04315740
- Acronym / sponsor ID
- Ultrafine / 191100
- Conditions
- Candle Burning, Cooking, Lung Function Decreased, DNA Damage, Subjective Health, Asthma
- Keywords
- Particle contamination, Indoor air, Acute health effects, RCT, Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- University of Copenhagen, Aarhus University Hospital
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 19 Mar 2020 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A randomised double-blinded crossover study
| Arm | Type | Receives |
|---|---|---|
| Clean Air | Sham comparator | Other: Clean AirJust clean air - no exposure |
| Cooking | Experimental | Other: Particles from cookingFour ovens were frying pork - one at a time. When the first oven finished, the next oven started and so forth for approx. 7 hours. |
| Candles | Experimental | Other: Particles from candles10 lit candles were placed at a table. Burning for approx. 7 hours with light ventilation. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Aged 15-25
- Medically treated / physician diagnosed mild seasonal asthma
- 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 |
|---|---|---|
| Particles from candlesGenerating fine and ultrafine particles from lit candles | Other | Candles |
| Particles from cookingGenerating fine and ultrafine particles from frying pork in an oven | Other | Cooking |
| Clean AirNothing but clean air | Other | Clean Air |
Primary outcome
Change in Particles in Exhaled Air (Surfactant Protein A & Albumin)
Time frame: 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 (novel) PExA® instrument set-up.
6 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 Blood samples
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: 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
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 6 Nov 2020.
- Individual participant dataSharing planned: No
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.
Karin R Laursen, MSc principal investigator
Department of Public Health, Aarhus Universitet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Particles from candles, Particles from cooking and Clean Air in people with Candle Burning and Cooking, 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 6 Nov 2020. 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. Some participants in this study may receive a placebo. 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: 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 6 Nov 2020.