Dose Response Relations for Health Effects Caused by Office Dust

This study has been completed.
Sponsor:
Collaborators:
The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
Service Branchens Arbejdsgiverforening i Danmark
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00143637
First received: September 1, 2005
Last updated: March 26, 2008
Last verified: March 2008
  Purpose

The study is focused at the dose response relation for office dust and such office dust spiked with components from fungi known from damp buildings.

The first aim of this study is to investigate if dust causes objective changes such as changes of lung function, nasal geometry, inflammatory indicators in tears and nasal lavage, tear film stability and cells at exposure levels relevant to indoor air. The controlled exposure variable is air concentration of office dust spiked with Glucan to simulate a worse case scenario.

Aim 1: Confirm or support the causality between objective effects and exposures to dust spiked with Glucan with focus on inflammatory responses. This is done by negation of the hypothesis that no significant effects are found for the variables in question.

Aim 2 is to estimate the thresholds and slopes of the DR relation for effect measures which show effects of exposures. At best the study will supply for each variable a zero response to clean air and three non-zero responses to dust. Thresholds and slopes are estimated graphically by linear regression or by an accumulated response model.

Aim 3 is a confirmation that atopic persons and histamine sensitive persons in nasal provocation tests have different responses in the effect measures showing significant effects of exposures to dust spiked with Glucan. Risk group status is therefore included in the analyses of the main variables as explaining variable.

Potential additional aim 4: Chemical and biological characterization of the office dust used in the study.

Aim 4 is an investigation of dose response relations for explorative measures, which in previous investigations have showed indications of a dose response relation. For these no a priory hypotheses exists and the analyses must be arranged ad hoc. The explaining variables are exposure and risk group status.

One challenge in investigations of unspecific effects caused by mixed exposures is that few specific objective effects measures are available and subjective measures have to be introduced. Therefore there is a need for developments of new objective measures of health effects of air pollution. Some of these are related to new biomarkers of respiratory effects in a bio-sample taken as condensed exhaled breath.

Aim 5: Developments of new objective measures of health effects of air pollution. After the experiment it will be investigated by logistic regression if a sensitivity index can be established.


Condition Intervention Phase
Discomfort Symptoms
Changed Lung Function
Other: Office dust
Other: clean air
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Dose Response Relations for Health Effects Caused by Office Dust.

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Lung Inflammation [ Time Frame: during exposures ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lung function [ Time Frame: during exposures ] [ Designated as safety issue: No ]
  • FEV [ Time Frame: during exposures ] [ Designated as safety issue: No ]
  • FVC [ Time Frame: during exposures ] [ Designated as safety issue: No ]
  • Acoustic rhinometry [ Time Frame: during exposures ] [ Designated as safety issue: No ]
  • cytokine profile [ Time Frame: during exposures ] [ Designated as safety issue: No ]
  • Peak expiratory flow [ Time Frame: during exposures ] [ Designated as safety issue: No ]
  • inflammation and sensory symptoms [ Time Frame: during exposures ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: May 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
Office dust with added glucan
Other: Office dust
airborne office dust spiked with glucan
Other Name: Glucan
Experimental: 1
Clean air exposures in climate chamber
Other: clean air
Clean air

Detailed Description:

The basic procedure is an exposure experiment in which human subjects are exposed to controlled variations of dust spiked with Glucan. Their responses are monitored before, after minutes and hours of exposure and later the same evening.

Two groups of subjects are selected in a pre-investigation using strict selection and exclusion criteria. The two groups are atopic persons and responders to Histamine in a RSM nasal provocation test.

The groups are exposed under controlled conditions in a climate chamber at IMA to office dust spiked with Glucan (same procedure and amount as in DAMOS) at clean air level (less than 20 micro-g/m3 (TSP) and at 150, 300 and 700 micro-g/m3 (TSP). In the pre-investigation and during the exposure sessions a number of personal characteristics are measured or registered to be used in the statistical analyses as explaining variables for the responses of the subjects.

The dust exposure will be characterized both though its size distribution and gravimetrically using up-to-date analytical instruments. To optimise the exposures several pilot studies are made. Only effects measures, which previously have shown clear indications of responses to dust exposures, are included in the study.

The timetable includes pre-investigations, two repetitions of the exposure design (run 1 and 2), analyses of the bio-samples, statistical analyses, and reporting.

The study includes a main study and several additional work-packages, which will be activated when funding become available.

  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

Exclusion Criteria:

  • Pregnancy
  • House dust allergy
  • Hyper-responding air ways, Disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00143637

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)
Service Branchens Arbejdsgiverforening i Danmark
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

Additional Information:
No publications provided

Responsible Party: Lars Mølhave Associate prof., Aarhus University
ClinicalTrials.gov Identifier: NCT00143637     History of Changes
Other Study ID Numbers: FORMAS 24.2/2003-0464, DORES2002
Study First Received: September 1, 2005
Last Updated: March 26, 2008
Health Authority: Sweden: Swedish National Council on Medical Ethics

Keywords provided by University of Aarhus:
Office dust
Glucan
dose-response
lung function
peak expiratory flow
inflammation
perception

ClinicalTrials.gov processed this record on April 17, 2014