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SENOC-I Det Sunda Huset II - Sensitization of Occupants of Water Damaged Buildings.

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ClinicalTrials.gov Identifier: NCT00143650
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : January 17, 2007
Sponsor:
Collaborator:
The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
Information provided by:
University of Aarhus

Brief 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. Does dust in general cause inflammatory/body perceptions through e.g. an irritation symptoms index.
  2. Does the dust include effective odorants which affects an IAQ index?
  3. 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)
  4. 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.


Condition or disease Intervention/treatment Phase
Upper Airway, Irritation Inflammation, Discomfort Behavioral: House dust Phase 1 Phase 2

Detailed Description:

The study is focussed on two main questions:

c. The importance of dampness of the building and home dust as a factor of the subjects= responses.

d. 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 Type : Interventional  (Clinical Trial)
Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
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?
Study Start Date : January 2001
Study Completion Date : September 2002



Primary Outcome Measures :
  1. Acoustic rhinometry, general symptoms, inflammation


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All in local area, nasal histamine responsive, grass allergic, from study KLINIR.

Exclusion Criteria:

  • Pregnancy, house dust allergy, hyper-responding air ways, disease, disabled

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00143650


Locations
Denmark
The Air Pollution Unit, Department of Environmental and Occupational Medicine, Institute of Public Health, The University of Aarhus
Aarhus,, Denmark, DK-8000,
Sponsors and Collaborators
University of Aarhus
The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
Investigators
Principal Investigator: Lars Mølhave,, DMSc, Ph.D. The Air Pollution Unit, Department of Environmental and Occupational Medicine, Institute of Public Health, The University of Aarhus

ClinicalTrials.gov Identifier: NCT00143650     History of Changes
Other Study ID Numbers: FORMAS 24.2/2001-05
SENOC,APU 0103.
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: January 17, 2007
Last Verified: January 2005

Keywords provided by University of Aarhus:
Upper airway, irritation inflammation, discomfort, house dust, damp buildings, climate chamber, humans

Additional relevant MeSH terms:
Inflammation
Pathologic Processes