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

Tracking Information

First Received Date ^ICMJE

September 1, 2005

Last Updated Date

January 16, 2007

Start Date ^ICMJE

January 2001

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Acoustic rhinometry, general symptoms, inflammation

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00143650 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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?

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Upper Airway, Irritation Inflammation, Discomfort

Intervention ^ICMJE

Behavioral: House dust

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2002

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 64 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00143650

Other Study ID Numbers ^ICMJE

FORMAS 24.2/2001-05, SENOC,APU 0103.

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University of Aarhus

Collaborators ^ICMJE

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

Investigators ^ICMJE

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

Information Provided By

University of Aarhus

Verification Date

January 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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