Controlled Exposure to Diesel Exhaust in Subjects With Allergic Rhinitis
DALLER
1 other identifier
interventional
14
1 country
1
Brief Summary
Proximity to traffic, particularly to diesel-powered heavy-duty vehicles, has been associated with inducing and enhancing allergies in children and adults. To investigate the basis for this association, a controlled exposure of allergic rhinitics to diesel exhaust was performed at a dose known to be pro-inflammatory in healthy individuals. The hypothesis was that airway inflammation would be augmented in allergic rhinitics following exposure to diesel exhaust at an environmentally pertinent particulate matter concentration. Fourteen allergic rhinitics were exposed in a double-blinded, randomised trial to both diesel exhaust at 100 microgram/m3 PM10 (representing an aerosol of nanoparticulate combustion particles, mean diameter 80 nm) and filtered air for two hours on separate occasions. Bronchoscopy with endobronchial mucosal biopsies and airway lavage was performed 18 hours post-exposure, and samples were analysed for markers of inflammation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2001
1 active site
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
March 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2002
CompletedFirst Submitted
Initial submission to the registry
June 5, 2012
CompletedFirst Posted
Study publicly available on registry
June 12, 2012
CompletedJune 12, 2012
June 1, 2012
11 months
June 5, 2012
June 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Airway inflammation
Bronchoscopy with endobronchial mucosal biopsies and airway lavage was performed 18 hours post-exposure to diesel exhaust and filtered air, and samples were analysed for markers of inflammation.
18 hours post exposure
Study Arms (2)
Diesel exhaust
EXPERIMENTAL2 hour exposure to diesel exhaust at 100 microgram per cubic meter during intermittent exercise
Filtered air exposure
EXPERIMENTAL2 hour exposure to filtered air during intermittent exercise
Interventions
Bronchoscopy with endobronchial biopsy sampling and bronchoalveolar lavage (BAL) 18 hours post exposure. Airway inflammation was assessed.
Eligibility Criteria
You may qualify if:
- History of seasonal allergic rhinitis requiring medical treatment only during the pollen season and were classified as mild and intermittent according to ARIA guidelines.
- Positive skin prick test to airborne allergens
- Normal lung function
- Negative Metacholine challenge
You may not qualify if:
- Current smoking or a previous history of smoking.
- Asthma
- Chest infection within six weeks prior to or during the study
- Current use of non-steroidal anti-inflammatory drugs
- Current vitamin C or E supplementation
- Current use of topical nasal steroids.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Umeålead
- King's College Londoncollaborator
Study Sites (1)
Department of Public Health and Clinical Medicine, Division of medicine, Pulmonary medicine
Umeå, Sverige, SE-90185, Sweden
Related Publications (5)
Morgenstern V, Zutavern A, Cyrys J, Brockow I, Koletzko S, Kramer U, Behrendt H, Herbarth O, von Berg A, Bauer CP, Wichmann HE, Heinrich J; GINI Study Group; LISA Study Group. Atopic diseases, allergic sensitization, and exposure to traffic-related air pollution in children. Am J Respir Crit Care Med. 2008 Jun 15;177(12):1331-7. doi: 10.1164/rccm.200701-036OC. Epub 2008 Mar 12.
PMID: 18337595BACKGROUNDGehring U, Wijga AH, Brauer M, Fischer P, de Jongste JC, Kerkhof M, Oldenwening M, Smit HA, Brunekreef B. Traffic-related air pollution and the development of asthma and allergies during the first 8 years of life. Am J Respir Crit Care Med. 2010 Mar 15;181(6):596-603. doi: 10.1164/rccm.200906-0858OC. Epub 2009 Dec 3.
PMID: 19965811BACKGROUNDOftedal B, Brunekreef B, Nystad W, Nafstad P. Residential outdoor air pollution and allergen sensitization in schoolchildren in Oslo, Norway. Clin Exp Allergy. 2007 Nov;37(11):1632-40. doi: 10.1111/j.1365-2222.2007.02823.x. Epub 2007 Sep 17.
PMID: 17877765BACKGROUNDBehndig AF, Larsson N, Brown JL, Stenfors N, Helleday R, Duggan ST, Dove RE, Wilson SJ, Sandstrom T, Kelly FJ, Mudway IS, Blomberg A. Proinflammatory doses of diesel exhaust in healthy subjects fail to elicit equivalent or augmented airway inflammation in subjects with asthma. Thorax. 2011 Jan;66(1):12-9. doi: 10.1136/thx.2010.140053. Epub 2010 Sep 13.
PMID: 20837873BACKGROUNDBrown JL, Behndig AF, Sekerel BE, Pourazar J, Blomberg A, Kelly FJ, Sandstrom T, Frew AJ, Wilson SJ. Lower airways inflammation in allergic rhinitics: a comparison with asthmatics and normal controls. Clin Exp Allergy. 2007 May;37(5):688-95. doi: 10.1111/j.1365-2222.2007.02695.x.
PMID: 17456216RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Annelie F Behndig, MD PhD
Department of Public Health and Clinical Medicine, Division of medicine, Umeå University, Umeå
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
June 5, 2012
First Posted
June 12, 2012
Study Start
March 1, 2001
Primary Completion
February 1, 2002
Study Completion
February 1, 2002
Last Updated
June 12, 2012
Record last verified: 2012-06