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

This study has been completed.
Sponsor:
Collaborator:
The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00143650
First received: September 1, 2005
Last updated: January 16, 2007
Last verified: January 2005
History of Changes
  Purpose

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 Intervention Phase
Upper Airway, Irritation Inflammation, Discomfort
 Behavioral: House dust
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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?

Resource links provided by NLM:

MedlinePlus related topics: Drinking Water
U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Acoustic rhinometry, general symptoms, inflammation

Estimated Enrollment: 27
Study Start Date: January 2001
Estimated Study Completion Date: September 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00143650     History of Changes
Other Study ID Numbers: FORMAS 24.2/2001-05, SENOC,APU 0103.
Study First Received: September 1, 2005
Last Updated: January 16, 2007
Health Authority: Sweden: Swedish National Council on Medical Ethics

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

ClinicalTrials.gov processed this record on May 16, 2013