Discomfort SymptomsPhase 1/2NCT00143637
Dose Response Relations for Health Effects Caused by Office Dust
A Phase 1/2 study testing Office dust and clean air in people with Discomfort Symptoms and Changed Lung Function, run by University of Aarhus at 1 site in Denmark.
Trial summary
The study is focused at the dose response relation for office dust and such office dust spiked with components from fungi known from damp buildings. The first aim of this study is to investigate if dust causes objective changes such as changes of lung function, nasal geometry, inflammatory indicators in tears and… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Discomfort Symptoms, Changed Lung Function
- What is being tested?
- Office dust and clean air
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- May 2005to Nov 2006
- Phase
- Phase 1/2
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All in local area
- Nasal histamine responsive
- Grass allergic
Who cannot join
- Pregnancy
- House dust allergy
- Hyper-responding air ways, Disease
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Air Pollution Unit, Department of Environmental and Occupational Medicine, Institute of Public Health, The University of Aarhus.
Aarhus, DK-8000
About this study
Official title: Dose Response Relations for Health Effects Caused by Office Dust.
The study is focused at the dose response relation for office dust and such office dust spiked with components from fungi known from damp buildings.
The first aim of this study is to investigate if dust causes objective changes such as changes of lung function, nasal geometry, inflammatory indicators in tears and nasal lavage, tear film stability and cells at exposure levels relevant to indoor air. The controlled exposure variable is air concentration of office dust spiked with Glucan to simulate a worse case scenario.
Read more
Aim 1: Confirm or support the causality between objective effects and exposures to dust spiked with Glucan with focus on inflammatory responses. This is done by negation of the hypothesis that no significant effects are found for the variables in question.
Aim 2 is to estimate the thresholds and slopes of the DR relation for effect measures which show effects of exposures. At best the study will supply for each variable a zero response to clean air and three non-zero responses to dust. Thresholds and slopes are estimated graphically by linear regression or by an accumulated response model.
Aim 3 is a confirmation that atopic persons and histamine sensitive persons in nasal provocation tests have different responses in the effect measures showing significant effects of exposures to dust spiked with Glucan. Risk group status is therefore included in the analyses of the main variables as explaining variable.
Potential additional aim 4: Chemical and biological characterization of the office dust used in the study.
Aim 4 is an investigation of dose response relations for explorative measures, which in previous investigations have showed indications of a dose response relation. For these no a priory hypotheses exists and the analyses must be arranged ad hoc. The explaining variables are exposure and risk group status.
One challenge in investigations of unspecific effects caused by mixed exposures is that few specific objective effects measures are available and subjective measures have to be introduced. Therefore there is a need for developments of new objective measures of health effects of air pollution. Some of these are related to new biomarkers of respiratory effects in a bio-sample taken as condensed exhaled breath.
Aim 5: Developments of new objective measures of health effects of air pollution. After the experiment it will be investigated by logistic regression if a sensitivity index can be established.
Read the detailed description
The basic procedure is an exposure experiment in which human subjects are exposed to controlled variations of dust spiked with Glucan. Their responses are monitored before, after minutes and hours of exposure and later the same evening.
Two groups of subjects are selected in a pre-investigation using strict selection and exclusion criteria. The two groups are atopic persons and responders to Histamine in a RSM nasal provocation test.
The groups are exposed under controlled conditions in a climate chamber at IMA to office dust spiked with Glucan (same procedure and amount as in DAMOS) at clean air level (less than 20 micro-g/m3 (TSP) and at 150, 300 and 700 micro-g/m3 (TSP). In the pre-investigation and during the exposure sessions a number of personal characteristics are measured or registered to be used in the statistical analyses as explaining variables for the responses of the subjects.
The dust exposure will be characterized both though its size distribution and gravimetrically using up-to-date analytical instruments. To optimise the exposures several pilot studies are made. Only effects measures, which previously have shown clear indications of responses to dust exposures, are included in the study.
The timetable includes pre-investigations, two repetitions of the exposure design (run 1 and 2), analyses of the bio-samples, statistical analyses, and reporting.
The study includes a main study and several additional work-packages, which will be activated when funding become available.
- Conditions
- Discomfort Symptoms, Changed Lung Function
- Being tested
- Office dust, clean air
- Keywords
- Office dust, Glucan, dose-response, lung function, peak expiratory flow, inflammation, perception
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Office dustOther
Also called Glucan
airborne office dust spiked with glucan
clean airOther
Clean air
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Office dust with added glucan Receives: Other: Office dust |
| 1 | Experimental | Clean air exposures in climate chamber Receives: Other: clean air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Inflammation
Measured: during exposures
Secondary outcomes (7)
Lung function
Measured: during exposures
FEV
Measured: during exposures
FVC
Measured: during exposures
Acoustic rhinometry
Measured: during exposures
cytokine profile
Measured: during exposures
Peak expiratory flow
Measured: during exposures
inflammation and sensory symptoms
Measured: during exposures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Discomfort SymptomsStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS), Service Branchens Arbejdsgiverforening i Danmark
- Investigators
- Lars Mølhave, DMSc, Ph.D., Principal investigator, The Air Pollution Unit, Department of Environmental and Occupational Medicine, Institute of Public Health, The University of Aarhus.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00143637
- Sponsor's protocol ID
- FORMAS 24.2/2003-0464
- Other IDs
- DORES2002
- Status last verified
- Mar 2008
- First submitted
- 1 Sep 2005
- Last updated
- 27 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Response Relations for Health Effects Caused by Office Dust.
- ClinicalTrials.gov ID
- NCT00143637
- Acronym / sponsor ID
- FORMAS 24.2/2003-0464
- Conditions
- Discomfort Symptoms, Changed Lung Function
- Keywords
- Office dust, Glucan, dose-response, lung function, peak expiratory flow, inflammation, perception
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS), Service Branchens Arbejdsgiverforening i Danmark
- Study start
- May 2005
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 2 Sep 2005 (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 study is focused at the dose response relation for office dust and such office dust spiked with components from fungi known from damp buildings.
The first aim of this study is to investigate if dust causes objective changes such as changes of lung function, nasal geometry, inflammatory indicators in tears and nasal lavage, tear film stability and cells at exposure levels relevant to indoor air. The controlled exposure variable is air concentration of office dust spiked with Glucan to simulate a worse case scenario.
Aim 1: Confirm or support the causality between objective effects and exposures to dust spiked with Glucan with focus on inflammatory responses. This is done by negation of the hypothesis that no significant effects are found for the variables in question.
Aim 2 is to estimate the thresholds and slopes of the DR relation for effect measures which show effects of exposures. At best the study will supply for each variable a zero response to clean air and three non-zero responses to dust. Thresholds and slopes are estimated graphically by linear regression or by an accumulated response model.
Aim 3 is a confirmation that atopic persons and histamine sensitive persons in nasal provocation tests have different responses in the effect measures showing significant effects of exposures to dust spiked with Glucan. Risk group status is therefore included in the analyses of the main variables as explaining variable.
Potential additional aim 4: Chemical and biological characterization of the office dust used in the study.
Aim 4 is an investigation of dose response relations for explorative measures, which in previous investigations have showed indications of a dose response relation. For these no a priory hypotheses exists and the analyses must be arranged ad hoc. The explaining variables are exposure and risk group status.
One challenge in investigations of unspecific effects caused by mixed exposures is that few specific objective effects measures are available and subjective measures have to be introduced. Therefore there is a need for developments of new objective measures of health effects of air pollution. Some of these are related to new biomarkers of respiratory effects in a bio-sample taken as condensed exhaled breath.
Aim 5: Developments of new objective measures of health effects of air pollution. After the experiment it will be investigated by logistic regression if a sensitivity index can be established.
Detailed description
The basic procedure is an exposure experiment in which human subjects are exposed to controlled variations of dust spiked with Glucan. Their responses are monitored before, after minutes and hours of exposure and later the same evening.
Two groups of subjects are selected in a pre-investigation using strict selection and exclusion criteria. The two groups are atopic persons and responders to Histamine in a RSM nasal provocation test.
The groups are exposed under controlled conditions in a climate chamber at IMA to office dust spiked with Glucan (same procedure and amount as in DAMOS) at clean air level (less than 20 micro-g/m3 (TSP) and at 150, 300 and 700 micro-g/m3 (TSP). In the pre-investigation and during the exposure sessions a number of personal characteristics are measured or registered to be used in the statistical analyses as explaining variables for the responses of the subjects.
The dust exposure will be characterized both though its size distribution and gravimetrically using up-to-date analytical instruments. To optimise the exposures several pilot studies are made. Only effects measures, which previously have shown clear indications of responses to dust exposures, are included in the study.
The timetable includes pre-investigations, two repetitions of the exposure design (run 1 and 2), analyses of the bio-samples, statistical analyses, and reporting.
The study includes a main study and several additional work-packages, which will be activated when funding become available.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Other: Office dustOffice dust with added glucan |
| 1 | Experimental | Other: clean airClean air exposures in climate chamber |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All in local area
- Nasal histamine responsive
- Grass allergic
Key exclusion criteria (3 listed)
- Pregnancy
- House dust allergy
- Hyper-responding air ways, Disease
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 |
|---|---|---|
| Office dustAlso: Glucanairborne office dust spiked with glucan | Other | 2 |
| clean airClean air | Other | 1 |
Primary outcome
Lung Inflammation
Time frame: during exposures
7 secondary outcomes
Lung function
Time frame: during exposures
FEV
Time frame: during exposures
FVC
Time frame: during exposures
Acoustic rhinometry
Time frame: during exposures
cytokine profile
Time frame: during exposures
Peak expiratory flow
Time frame: during exposures
inflammation and sensory symptoms
Time frame: during exposures
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 27 Mar 2008.
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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.
Lars Mølhave, DMSc, Ph.D. principal investigator
The Air Pollution Unit, Department of Environmental and Occupational Medicine, Institute of Public Health, The 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 Phase 1/2 study testing Office dust and clean air in people with Discomfort Symptoms and Changed Lung Function, 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 3 inclusion and 3 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 27 Mar 2008. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Lung Inflammation (time frame: during exposures). 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 27 Mar 2008.