NCT00143637

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

March 27, 2008

Status Verified

March 1, 2008

Enrollment Period

1.5 years

First QC Date

September 1, 2005

Last Update Submit

March 26, 2008

Conditions

Discomfort SymptomsChanged Lung Function

Keywords

Office dustGlucandose-responselung functionpeak expiratory flowinflammationperception

Outcome Measures

Primary Outcomes (1)

  • Lung Inflammation

    during exposures

Secondary Outcomes (7)

  • Lung function

    during exposures

  • FEV

    during exposures

  • FVC

    during exposures

  • Acoustic rhinometry

    during exposures

  • cytokine profile

    during exposures

  • +2 more secondary outcomes

Study Arms (2)

2

EXPERIMENTAL

Office dust with added glucan

Other: Office dust

1

EXPERIMENTAL

Clean air exposures in climate chamber

Other: clean air

Interventions

Office dustOTHER

airborne office dust spiked with glucan

Also known as: Glucan
2
clean airOTHER

Clean air

1

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All in local area
  • Nasal histamine responsive
  • Grass allergic

You may not qualify if:

  • Pregnancy
  • House dust allergy
  • Hyper-responding air ways, Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Aarhus, DK-8000, Denmark

Location

MeSH Terms

Conditions

Inflammation

Interventions

GlucansEnvironment, Controlled

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesEnvironmentEnvironment and Public Health

Study Officials

  • Lars Mølhave, DMSc, Ph.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

May 1, 2005

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

March 27, 2008

Record last verified: 2008-03

Locations

DK(1)