Completed

NCT Number: NCT00143650

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

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.

Completed

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Key information

Conditions

Upper Airway, Irritation Inflammation, Discomfort

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Aarhus, DK-8000,, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

House dust

Behavioral

Primary outcomes

Acoustic rhinometry, general symptoms, inflammation

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)

Registry information

Official study 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?

Important dates

Study start: 2001
Study completion: 2002
First posted: Sep 2, 2005
Registry last updated: Jan 17, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.