Controlled Exposure to Diesel Exhaust in Subjects With Allergic Rhinitis - Full Text View

Purpose

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.

Condition	Intervention
Allergic Rhinitis	Procedure: Bronchoscopy

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
Official Title:	Controlled Exposure to Diesel Exhaust in Subjects With Allergic Rhinitis

Resource links provided by NLM:

MedlinePlus related topics: Air Pollution

U.S. FDA Resources

Further study details as provided by University Hospital, Umeå:

Primary Outcome Measures:

Airway inflammation [ Time Frame: 18 hours post exposure ] [ Designated as safety issue: No ]
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.

Enrollment:	14
Study Start Date:	March 2001
Study Completion Date:	February 2002
Primary Completion Date:	February 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Diesel exhaust 2 hour exposure to diesel exhaust at 100 microgram per cubic meter during intermittent exercise	Procedure: Bronchoscopy Bronchoscopy with endobronchial biopsy sampling and bronchoalveolar lavage (BAL) 18 hours post exposure. Airway inflammation was assessed. Other Names: Particulate matter Air pollution BAL
Experimental: Filtered air exposure 2 hour exposure to filtered air during intermittent exercise	Procedure: Bronchoscopy Bronchoscopy with endobronchial biopsy sampling and bronchoalveolar lavage (BAL) 18 hours post exposure. Airway inflammation was assessed. Other Names: Particulate matter Air pollution BAL

Eligibility

Ages Eligible for Study:	20 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617330

Locations

Sweden
Department of Public Health and Clinical Medicine, Division of medicine, Pulmonary medicine
Umeå, Sverige, Sweden, SE-90185

Sponsors and Collaborators

University Hospital, Umeå

King's College London

Investigators

Principal Investigator:

Annelie F Behndig, MD PhD

Department of Public Health and Clinical Medicine, Division of medicine, Umeå University, Umeå

More Information

Publications:

Brown JL, Behndig AF, Sekerel BE, Pourazar J, Blomberg A, Kelly FJ, Sandström 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.

Morgenstern V, Zutavern A, Cyrys J, Brockow I, Koletzko S, Krämer 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. Epub 2008 Mar 12.

Gehring 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. Epub 2009 Dec 3.

Oftedal 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. Epub 2007 Sep 17.

Behndig 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. Epub 2010 Sep 13.

Responsible Party:	Dr Annelie F Behndig, MD PhD, MD PhD, University Hospital, Umeå
ClinicalTrials.gov Identifier:	NCT01617330 History of Changes
Other Study ID Numbers:	DALLER
Study First Received:	June 5, 2012
Last Updated:	June 11, 2012
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by University Hospital, Umeå:

Particulate matter
Air pollution
Diesel exhaust
Allergic rhinitis

Additional relevant MeSH terms:

Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013

Controlled Exposure to Diesel Exhaust in Subjects With Allergic Rhinitis (DALLER)