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

Upper Airway, Irritation Inflammation, Discomfort Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00143650
• Other study ID #: FORMAS 24.2/2001-05
• Secondary ID: SENOC,APU 0103.
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 1, 2005
• Last updated: January 16, 2007
• Start date: January 2001
• Est. completion date: September 2002

Study information

• Verified date: January 2005
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish National Council on Medical Ethics
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Inflammation
• Upper Airway, Irritation Inflammation, Discomfort

Intervention

Behavioral:
• House dust

Locations

Country	Name	City	State
Denmark	The Air Pollution Unit, Department of Environmental and Occupational Medicine, Institute of Public Health, The University of Aarhus	Aarhus,

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acoustic rhinometry, general symptoms, inflammation