HIPWOODS - Health Effects Related to Exposure to Particle Pollution From Woodburning Stoves

NCT00673907 | Completed

• 2 other identifiers: 2104-05-0003Projekt nr: 0502-
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The study intends to focus on health effects and symptoms related to particle exposure from wood burning stoves The objective is to determine whether moderate exposure to particles from wood smoke in a real life situation causes an systemic inflammatory response in peripheral blood or in lower airways. 24 healthy subjects (normal healthy subjects and mild asthmatics to study the asthmatic response) is selected for the study. A randomized double blind crossover procedure will be followed with a PM exposure concentration of 200ug/m3, 400ug/m3 or clean air as the control exposure. Exposure will take place in a climate chamber using wood burning in an appropriate wood stove.

Conditions

Airway Inflammation; Systemic Inflammation

Keywords

Wood smoke; Health effects; Human; Airway inflammation; Cardiovascular effects

Outcome Measures

Primary Outcomes (1)

• Different Inflammation Biomarkers

  Baseline and follow up measurement after exposure 0 hours post, a 6 hours post and 20 hours post.

Secondary Outcomes (1)

• Baseline and follow up measurements are: spirometry, exhaled breath condensate, nasal lavage, nasal patency, blood sampling and symptoms.

  Baseline and follow up measurement after exposure 0 hours post, a 6 hours post and 20 hours post.

Study Arms (3)

1

SHAM COMPARATOR

Clean air

Other: Wood smoke particles

2

EXPERIMENTAL

Wood smoke particle concentration of 200 ug/m3

Other: Wood smoke particles

3

EXPERIMENTAL

Wood smoke particle concentration of 400 ug/m3

Other: Wood smoke particles

Interventions

Wood smoke particles OTHER

Subjects are exposed at rest to the exposures for 3 h in our climate chamber

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Twenty-four, non-smoking atopic volunteers with normal lung function and bronchial reactivity are recruited for the study. Atopy is determined by skin-prick testing to common aeroallergens.

You may not qualify if:

• Smokers, pregnant women and other subjects with current or previous diseases, which could involve a risk for the subject or possibly influence the outcome measurements, will be excluded from the study.

Sponsors & Collaborators

• University of Aarhus: lead
• University of Copenhagen: collaborator
• Aarhus University Hospital: collaborator

Study Sites (1)

Institute of Environmental and Occupational Medicine , Institute of Public Health , The Faculty of Health Sciences

Aarhus C, 8000, Denmark

Location

Study Officials

• Torben Sigsgaard, Professor

  Department of Environmental and Occupational Medicine , Institute of Public Health , The Faculty of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2008
• First Posted: May 7, 2008
• Study Start: January 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: November 1, 2009
• Last Updated: February 2, 2012

Record last verified: 2012-02

Locations

DK (1)