Subjective DiscomfortXDOZNCT02017782
Controlled Human Exposure to Indoor Air, Dust and Ozone
A study testing Dust, Ozone and Dust and Ozone in people with Subjective Discomfort and General Mucosal Irritation, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim of the study is to provide information which may help to improve the quality of the life of persons exposed to indoor environments in Danish dwellings. The experiment will document if dust and ozone contribute to deterioration of indoor air quality and to the occurrence of symptoms and health effects. Read more about this study
- Who is it for?
- Ages 60 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Subjective Discomfort, General Mucosal Irritation, Acute Changes in Respiratory Outcomes
- What is being tested?
- Dust, Ozone and Dust and Ozone
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2013to Jul 2013
- 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 60 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-smoker
- Normal lung function
- No active allergic rhinitis
- Be free from clinically significant cardiac, pulmonary, neurological and psychiatric disease as determined by medical history, physical examination and screening investigations.
- With no clinically-significant deviation outside the normal ranges for blood presure and pulse Measurements.
- Capable of giving informed consent
- Be avaible to complete the study
- Provide oral and written informed consent to participate in the study
Who cannot join
- Atopy
- Upper respiratory tract infection within 2 weeks
- Medical conditions likely to affect the outcome of the study in the opion of the investigator.
- Presence of any respiratory disease
- Infection of the upper Airways/lower Airways includingviral infections in the 14 days prior to screening and at the start of/or during the study.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University, Scholle of Public Health, Dept. of Environmental & Occupational Medicine
Aarhus, 8000
About this study
The aim of the study is to provide information which may help to improve the quality of the life of persons exposed to indoor environments in Danish dwellings.
The experiment will document if dust and ozone contribute to deterioration of indoor air quality and to the occurrence of symptoms and health effects.
Read more
The study is aimed at testing the hypothesis that the presence of ozone potentiate the health and comfort effects of dust exposure in the indoor environment.
Testing this hypothesis will be based on the following questions:
Does house dust and ozone in concentrations frequently encountered in Danish dwellings cause unwanted health effects either by themselves or by interaction?
If so, does the presence of ozone potentiate the expected irritative effects of dust?
The challenge of these hypotheses will be made as a controlled experiment on humans in a climate chamber under controlled exposure conditions.
This controlled human experiment should be able to substantiate the findings from the intervention studies.
Furthermore, they ideally reflect something relevant to the general public and therefore should have maximum public appeal and application possibilities.
Read the detailed description
This study is a part of a broader research programme established by CISBO ( Centre for Indoor air and Health in Dwellings). The purpose of the centre is to increase the general knowledge and to provide information on indoor air quality and related Health effects. The study may contribute with basic information on underlying pathophysiological mechanisms involved in human responses to these pollutants and in their interactive effects. The study includes as methods and techniques to detect minor changes in biomarkers suggesting early effect of exposure. These analyses will give information at a high sensitive level about the exposure effects on biomarkers for an array of symptoms and reactions.
The study Group consitss of 24 non-smoking persons(aged 60-70). A controlled, randomized and balanced Latin square cross-over design using the participants as their own controls. The exposures are arranged in a full-scale climate chamber where the participants will be exposed for 5½ hour under controlled environmental conditions.
The exposure facility (Climate chamber):
The exposures are arranged at the controlled experimental facilities at our department which include climate chambers and exposure generators for dust and ozone. The exposure sessions will take place under controlled conditions in a 79 m3 climate chamber made of welded stainless steel optimized for experiments with gasses and particulate air pollutants. The chamber facility allows exposures with controlled ventilation, temperature and air humidity and has an efficient mixing of ventilation air with the chamber air.
All participants will attend all four diff. exposure sessions:
Dust (250-300µg/m3), Ozone (0,1ppm ozone),Dust+ozone (250-300µg/m3 + 0,1 ppm ozone), Filtered air (<20µg/m3). with at least 2 weeks between each exposure session to eliminate hang-over effects. The filtered air and dust and ozone contaminated sessions will be identical except for the air quality. The exposures are unknown to the participants and staff to keep the study double blinded. The blinding will be continued until the basic statistical analyses have been conducted.
Selected subjective and objective health outcomes are measured at baseline and at follow-up at predefined time points.
Health assessment and Measurements includes:
Subjective symptoms, Respiratory outcomes (lung function, FENO, exhaled breath condensate, nasal lavages, Acoustic Rhinometri) Blood samples (inflammation biomarkers)
- Conditions
- Subjective Discomfort, General Mucosal Irritation, Acute Changes in Respiratory Outcomes, Acute Changes in Cardiovascular Outcomes, Changes in Biomarkers
- Being tested
- Dust, Ozone, Dust and Ozone, Placebo (Filtered air)
- Keywords
- Dust, Ozone, Indoor air quality, Indoor environment, Indoor climate, Cardiovascular diseases, Full body exposure, Exposure experiment with dust and ozone, Acute exposure to ozone and dust, Respiratory outcomes, Cardiovascular outcomes, Acoustic rhinometry, Body inflammatory markers, Cytokines, Exhaled FeNO, Nasal Lavage, Heart rate variability, Blood biomarkers, Subjective discomfort, General mucosal irritation
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DustDevice
Dust (250-300µg/m3),
OzoneDevice
(0,1ppm ozone),
Dust and OzoneDevice
Active Dust (250-300 ug/m3)+Ozone(0,1ppm)
Placebo (Filtered air)Device
Placebo treatment (Filtered air <20 ug/m3)
| Study group | Role | What they receive |
|---|---|---|
| Dust, Ozone, Interaction Dust & Ozone | Experimental | Dust (250-300µg/m3), Ozone (0,1ppm ozone),Dust+Ozone (250-300µg/m3 + 0,1 ppm ozone), Filtered air (<20µg/m3). with at least 2 weeks between each exposure session Receives: Device: Dust; Device: Ozone |
| Interaction Dust & Ozone and placebo Filtered air | Active comparator | Dust+Ozone (250-300µg/m3 + 0,1 ppm ozone), Filtered air (<20µg/m3) with at least 2 weeks between each exposure session. Receives: Device: Dust; Device: Ozone; Device: Dust and Ozone; Device: Placebo (Filtered air) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Causes of subjective Health effects from dust, ozone and interaction with dust and ozone as air pollutants compared to exposing with placebo filtered air.
To assess the subjective discomfort from dust and ozone. The subjective baseline and follow-up Health Measurements includes completing a computerbased symptom and comfort questionnaire. Three indexes were used: Index for Irritated Body perceptions (IBP) consisting of the individual symptoms eye irritation, throat irritation and nose irritation, Index for Lower Respiratory Effects (LRE) consisting of perceptions of cough, shortness of breath and tightness of breath and finally the Index for Weak Inflammatory Response (WIR) consisting of eye irritation, dry eyes, watering eyes, throat irritaion, nose irritaion and itching skin.
Measured: The Health outcomes were conducted at baseline, immediately after exposure (½ + 3½ hours) and the end of exposure (5½ post exposure initiation).
Secondary outcomes (5)
To assess changes in blood biomarkers compared with exposing with placebo filtered air.
To assess the changes in blood biomarkers develop in participants exposed to the four treatments. Blood samples will be conducted by taking a venous blood sample.Blood plasma will be frozen, and following analyzed for substances related to both allergic and non-allergic immune responses, e.g.cytokines IL-4, IL-5 and TNF.
Measured: The blood samples were conducted at baseline, in the end of exposure (5½ post exposure initiation) and follow-up (24 hours)
To assess changes in concentrations of cytokines in nasal lavage fluid.
To assess changes of concentrations of cytokines (TNF, IL-6, IL-8) in nasal lavage fluid develop in patient exposed to filtered air compared to the same patients in an exposed environment with dust and ozone.
Measured: The lavage samples were conducted at the pre-exposure and in the end of exposure (5½ post exposure initiation).
To assess changes in the intranasal volume measured by acoustic rhinometry (AR)
The assessment will be based on the difference between minimum and maximum volume as determined by acoustic rhinometry. The minimum cross-sectional area will be calculated and the area-distance curve Integrated to determine the volumes at a distance of two to four centimetres from the nostril.
Measured: During the study day Measurements for AR will be performed at baseline, immediately following exposure and at the end of the study day (at 5½ hours from baseline)
To assess changes in the epithelial plasticity with Endopat measures.
The EndoPAT is a medical device for noninvasive endothelial function assessment. It measures endothelium-mediated changes in vascular tone using bio-sensors placed on the fingertips. These changes in arterial tone are elicited by creating a down-stream hyperemic response induced by a standard 5-minute occlusion of the brachial artery. Measurements from the contra-lateral arm are used to control for concurrent non-endothelial dependent changes in vascular tone. The automatically calculated result is an index of endothelial function. The EndoPAT detects plethysmographic pressure changes in the finger tips caused by the arterial pulse and translates this to a peripheral arterial tone (PAT).
Measured: The EndoPat was conducted in the end of exposure (5½ post exposure initiation).
To assess changes in Forced Expiratory Volume (FEV1)
The participants´ lung function was recorded using a Micro DL spirometer
Measured: On each study day : baseline, 30 min., 3½hour, 5½ post-exposure and in 3 hour intervals for 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective DiscomfortStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Torben Sigsgaard, Professor, Principal investigator, University of Aarhus, School of Public Health, Dept. of Environment and Occupational Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017782
- Sponsor's protocol ID
- XDOZ-1201
- Other IDs
- 1201
- Acronym
- XDOZ
- Status last verified
- Apr 2013
- First submitted
- 5 Dec 2013
- Last updated
- 23 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Human Exposure to Indoor Air, Dust and Ozone
- ClinicalTrials.gov ID
- NCT02017782
- Acronym / sponsor ID
- XDOZ / XDOZ-1201
- Conditions
- Subjective Discomfort, General Mucosal Irritation, Acute Changes in Respiratory Outcomes, Acute Changes in Cardiovascular Outcomes, Changes in Biomarkers
- Keywords
- Dust, Ozone, Indoor air quality, Indoor environment, Indoor climate, Cardiovascular diseases, Full body exposure, Exposure experiment with dust and ozone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 23 Dec 2013 (estimated)
- 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.
The aim of the study is to provide information which may help to improve the quality of the life of persons exposed to indoor environments in Danish dwellings.
The experiment will document if dust and ozone contribute to deterioration of indoor air quality and to the occurrence of symptoms and health effects.
The study is aimed at testing the hypothesis that the presence of ozone potentiate the health and comfort effects of dust exposure in the indoor environment.
Testing this hypothesis will be based on the following questions:
Does house dust and ozone in concentrations frequently encountered in Danish dwellings cause unwanted health effects either by themselves or by interaction?
If so, does the presence of ozone potentiate the expected irritative effects of dust?
The challenge of these hypotheses will be made as a controlled experiment on humans in a climate chamber under controlled exposure conditions.
This controlled human experiment should be able to substantiate the findings from the intervention studies.
Furthermore, they ideally reflect something relevant to the general public and therefore should have maximum public appeal and application possibilities.
Detailed description
This study is a part of a broader research programme established by CISBO ( Centre for Indoor air and Health in Dwellings). The purpose of the centre is to increase the general knowledge and to provide information on indoor air quality and related Health effects. The study may contribute with basic information on underlying pathophysiological mechanisms involved in human responses to these pollutants and in their interactive effects. The study includes as methods and techniques to detect minor changes in biomarkers suggesting early effect of exposure. These analyses will give information at a high sensitive level about the exposure effects on biomarkers for an array of symptoms and reactions.
The study Group consitss of 24 non-smoking persons(aged 60-70). A controlled, randomized and balanced Latin square cross-over design using the participants as their own controls. The exposures are arranged in a full-scale climate chamber where the participants will be exposed for 5½ hour under controlled environmental conditions.
The exposure facility (Climate chamber):
The exposures are arranged at the controlled experimental facilities at our department which include climate chambers and exposure generators for dust and ozone. The exposure sessions will take place under controlled conditions in a 79 m3 climate chamber made of welded stainless steel optimized for experiments with gasses and particulate air pollutants. The chamber facility allows exposures with controlled ventilation, temperature and air humidity and has an efficient mixing of ventilation air with the chamber air.
All participants will attend all four diff. exposure sessions:
Dust (250-300µg/m3), Ozone (0,1ppm ozone),Dust+ozone (250-300µg/m3 + 0,1 ppm ozone), Filtered air (<20µg/m3). with at least 2 weeks between each exposure session to eliminate hang-over effects. The filtered air and dust and ozone contaminated sessions will be identical except for the air quality. The exposures are unknown to the participants and staff to keep the study double blinded. The blinding will be continued until the basic statistical analyses have been conducted.
Selected subjective and objective health outcomes are measured at baseline and at follow-up at predefined time points.
Health assessment and Measurements includes:
Subjective symptoms, Respiratory outcomes (lung function, FENO, exhaled breath condensate, nasal lavages, Acoustic Rhinometri) Blood samples (inflammation biomarkers)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dust, Ozone, Interaction Dust & Ozone | Experimental | Device: Dust, Device: OzoneDust (250-300µg/m3), Ozone (0,1ppm ozone),Dust+Ozone (250-300µg/m3 + 0,1 ppm ozone), Filtered air (<20µg/m3). with at least 2 weeks between each exposure session |
| Interaction Dust & Ozone and placebo Filtered air | Active comparator | Device: Dust, Device: Ozone, Device: Dust and Ozone, Device: Placebo (Filtered air)Dust+Ozone (250-300µg/m3 + 0,1 ppm ozone), Filtered air (<20µg/m3) with at least 2 weeks between each exposure session. |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Non-smoker
- Normal lung function
- No active allergic rhinitis
- Be free from clinically significant cardiac, pulmonary, neurological and psychiatric disease as determined by medical history, physical examination and screening investigations.
- With no clinically-significant deviation outside the normal ranges for blood presure and pulse Measurements.
Key exclusion criteria (5 listed)
- Atopy
- Upper respiratory tract infection within 2 weeks
- Medical conditions likely to affect the outcome of the study in the opion of the investigator.
- Presence of any respiratory disease
- Infection of the upper Airways/lower Airways includingviral infections in the 14 days prior to screening and at the start of/or during the study.
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 |
|---|---|---|
| DustDust (250-300µg/m3), | Device | Dust, Ozone, Interaction Dust & Ozone, Interaction Dust & Ozone and placebo Filtered air |
| Ozone(0,1ppm ozone), | Device | Dust, Ozone, Interaction Dust & Ozone, Interaction Dust & Ozone and placebo Filtered air |
| Dust and OzoneActive Dust (250-300 ug/m3)+Ozone(0,1ppm) | Device | Interaction Dust & Ozone and placebo Filtered air |
| Placebo (Filtered air)Placebo treatment (Filtered air <20 ug/m3) | Device | Interaction Dust & Ozone and placebo Filtered air |
Primary outcome
Causes of subjective Health effects from dust, ozone and interaction with dust and ozone as air pollutants compared to exposing with placebo filtered air.
Time frame: The Health outcomes were conducted at baseline, immediately after exposure (½ + 3½ hours) and the end of exposure (5½ post exposure initiation).
To assess the subjective discomfort from dust and ozone. The subjective baseline and follow-up Health Measurements includes completing a computerbased symptom and comfort questionnaire. Three indexes were used: Index for Irritated Body perceptions (IBP) consisting of the individual symptoms eye irritation, throat irritation and nose irritation, Index for Lower Respiratory Effects (LRE) consisting of perceptions of cough, shortness of breath and tightness of breath and finally the Index for Weak Inflammatory Response (WIR) consisting of eye irritation, dry eyes, watering eyes, throat irritaion, nose irritaion and itching skin.
5 secondary outcomes
To assess changes in blood biomarkers compared with exposing with placebo filtered air.
Time frame: The blood samples were conducted at baseline, in the end of exposure (5½ post exposure initiation) and follow-up (24 hours)
To assess changes in concentrations of cytokines in nasal lavage fluid.
Time frame: The lavage samples were conducted at the pre-exposure and in the end of exposure (5½ post exposure initiation).
To assess changes in the intranasal volume measured by acoustic rhinometry (AR)
Time frame: During the study day Measurements for AR will be performed at baseline, immediately following exposure and at the end of the study day (at 5½ hours from baseline)
To assess changes in the epithelial plasticity with Endopat measures.
Time frame: The EndoPat was conducted in the end of exposure (5½ post exposure initiation).
To assess changes in Forced Expiratory Volume (FEV1)
Time frame: On each study day : baseline, 30 min., 3½hour, 5½ post-exposure and in 3 hour intervals for 24 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 23 Dec 2013.
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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, Professor principal investigator
University of Aarhus, School of Public Health, Dept. of Environment and Occupational Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dust, Ozone and Dust and Ozone in people with Subjective Discomfort and General Mucosal Irritation, 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 8 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 23 Dec 2013. 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?
Causes of subjective Health effects from dust, ozone and interaction with dust and ozone as air pollutants compared to exposing with placebo filtered air. (time frame: The Health outcomes were conducted at baseline, immediately after exposure (½ + 3½ hours) and the end of exposure (5½ post exposure initiation).). 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 23 Dec 2013.