Upper Airway, Irritation Inflammation, DiscomfortPhase 1/2NCT00143650
SENOC-I Det Sunda Huset II - Sensitization of Occupants of Water Damaged Buildings.
A Phase 1/2 study testing House dust in people with Upper Airway, Irritation Inflammation, Discomfort, run by University of Aarhus at 1 site in Denmark.
Trial summary
The study is focussed on two main questions: 1. The importance of dampness of the building and home dust as a factor of the subjects= responses. 2. Can measures used in KLINIR predict the subjects' responses to the dust? This study therefore was arranged to test the following hypotheses: 1. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Airway, Irritation Inflammation, Discomfort
- What is being tested?
- House dust
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 27 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2001to Sep 2002
- 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, from study KLINIR.
Who cannot join
- Pregnancy, house dust allergy, hyper-responding air ways, disease, disabled
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: Does House Dust From Water Damaged Buildings Cause Stronger Responses Among Occupants Than Dust From Buildings Without Water Damage? Can Occupants' Sensitivity be Predicted by Biomarkers?
The study is focussed on two main questions:
- The importance of dampness of the building and home dust as a factor of the subjects= responses.
- Can measures used in KLINIR predict the subjects' responses to the dust?
Read more
This study therefore was arranged to test the following hypotheses:
- Does dust in general cause inflammatory/body perceptions through e.g. an irritation symptoms index.
- Does the dust include effective odorants which affects an IAQ index?
- Does dampness increase the content of organic or inorganic compounds e.g. of microbial origin that causes the dust to be more reactive? (Differences between the two types of dust)
- Is the sensitivity of the subjects explaining the responses to exposures in a, b, or c? (Subject group and sensitivity index)
As explorative investigations biomarkers for exposures and sensitivity for practical usage are tested.
Read the detailed description
The study is focussed on two main questions:
- The importance of dampness of the building and home dust as a factor of the subjects= responses.
- Can measures used in KLINIR predict the subjects' responses to the dust?
As explorative investigations biomarkers for exposures and sensitivity are tested for practical use.
These investigations are made during experimental exposures of subjects to dust from dry and water damaged buildings. The responses of healthy KLINIR-sensitive subjects are predicted using personal sensitivity measures.
The design is a 3x3 Latin square design (cross-over design). The subjects will be their own controls and comparisons to placebo (clean air) were made. The study was double blinded and the subjects were only informed about details on design and exposures after the experiment and only if they asked.
This design eliminated effects of any learning or training during the investigations, and also the effects of season and weekday was eliminated. The subjects were exposed with 3-4 weeks interval to eliminate carry-over of effects from one exposure session to the next.
The design was replicated three times on three different groups of subjects each including 9 subjects. Each group of nine were divided into three groups of three subjects.
- Being tested
- House dust
- Keywords
- Upper airway, irritation inflammation, discomfort, house dust, damp buildings, climate chamber, humans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
House dustBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Acoustic rhinometry, general symptoms, inflammation
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 startJan 2001
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Airway, Irritation Inflammation, 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 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 27 participants
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)
- 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
- NCT00143650
- Sponsor's protocol ID
- FORMAS 24.2/2001-05
- Other IDs
- SENOC,APU 0103.
- Status last verified
- Jan 2005
- First submitted
- 1 Sep 2005
- Last updated
- 17 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does House Dust From Water Damaged Buildings Cause Stronger Responses Among Occupants Than Dust From Buildings Without Water Damage? Can Occupants' Sensitivity be Predicted by Biomarkers?
- ClinicalTrials.gov ID
- NCT00143650
- Acronym / sponsor ID
- FORMAS 24.2/2001-05
- Keywords
- Upper airway, irritation inflammation, discomfort, house dust, damp buildings, climate chamber, humans
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
- Study start
- Jan 2001
- Study completion
- Sep 2002
- 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 focussed on two main questions:
- The importance of dampness of the building and home dust as a factor of the subjects= responses.
- Can measures used in KLINIR predict the subjects' responses to the dust?
This study therefore was arranged to test the following hypotheses:
- Does dust in general cause inflammatory/body perceptions through e.g. an irritation symptoms index.
- Does the dust include effective odorants which affects an IAQ index?
- Does dampness increase the content of organic or inorganic compounds e.g. of microbial origin that causes the dust to be more reactive? (Differences between the two types of dust)
- Is the sensitivity of the subjects explaining the responses to exposures in a, b, or c? (Subject group and sensitivity index)
As explorative investigations biomarkers for exposures and sensitivity for practical usage are tested.
Detailed description
The study is focussed on two main questions:
- The importance of dampness of the building and home dust as a factor of the subjects= responses.
- Can measures used in KLINIR predict the subjects' responses to the dust?
As explorative investigations biomarkers for exposures and sensitivity are tested for practical use.
These investigations are made during experimental exposures of subjects to dust from dry and water damaged buildings. The responses of healthy KLINIR-sensitive subjects are predicted using personal sensitivity measures.
The design is a 3x3 Latin square design (cross-over design). The subjects will be their own controls and comparisons to placebo (clean air) were made. The study was double blinded and the subjects were only informed about details on design and exposures after the experiment and only if they asked.
This design eliminated effects of any learning or training during the investigations, and also the effects of season and weekday was eliminated. The subjects were exposed with 3-4 weeks interval to eliminate carry-over of effects from one exposure session to the next.
The design was replicated three times on three different groups of subjects each including 9 subjects. Each group of nine were divided into three groups of three subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All in local area, nasal histamine responsive, grass allergic, from study KLINIR.
Key exclusion criteria (1 listed)
- Pregnancy, house dust allergy, hyper-responding air ways, disease, disabled
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 |
|---|---|---|
| House dust | Behavioural | – |
Primary outcome
Acoustic rhinometry, general symptoms, inflammation
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 17 Jan 2007.
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 House dust in people with Upper Airway, Irritation Inflammation, Discomfort, 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 1 inclusion and 1 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 17 Jan 2007. 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?
Acoustic rhinometry, general symptoms, inflammation. 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 17 Jan 2007.