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

Primary Purpose

Upper Airway, Irritation Inflammation, Discomfort

Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
House dust
Sponsored by
University of Aarhus
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Upper Airway, Irritation Inflammation, Discomfort focused on measuring Upper airway, irritation inflammation, discomfort, house dust, damp buildings, climate chamber, humans

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Air Pollution Unit, Department of Environmental and Occupational Medicine, Institute of Public Health, The University of Aarhus

Outcomes

Primary Outcome Measures

Acoustic rhinometry, general symptoms, inflammation

Secondary Outcome Measures

Full Information

First Posted
September 1, 2005
Last Updated
January 16, 2007
Sponsor
University of Aarhus
Collaborators
The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
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1. Study Identification

Unique Protocol Identification Number
NCT00143650
Brief Title
SENOC-I Det Sunda Huset II - Sensitization of Occupants of Water Damaged Buildings.
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 Type
Interventional

2. Study Status

Record Verification Date
January 2005
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Aarhus
Collaborators
The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)

4. Oversight

5. Study Description

Brief Summary
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Airway, Irritation Inflammation, Discomfort
Keywords
Upper airway, irritation inflammation, discomfort, house dust, damp buildings, climate chamber, humans

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Non-Randomized
Enrollment
27 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
House dust
Primary Outcome Measure Information:
Title
Acoustic rhinometry, general symptoms, inflammation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Mølhave,, DMSc, Ph.D.
Organizational Affiliation
The Air Pollution Unit, Department of Environmental and Occupational Medicine, Institute of Public Health, The University of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Air Pollution Unit, Department of Environmental and Occupational Medicine, Institute of Public Health, The University of Aarhus
City
Aarhus,
ZIP/Postal Code
DK-8000,
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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