Controlled Exposure to Diesel Exhaust in Subjects With Allergic Rhinitis

Allergic Rhinitis Clinical Trial

— DALLER  

Official title:

Controlled Exposure to Diesel Exhaust in Subjects With Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01617330
• Other study ID #: DALLER
• Status: Completed
• Phase: N/A
• First received: June 5, 2012
• Last updated: June 11, 2012
• Start date: March 2001
• Est. completion date: February 2002

Study information

• Verified date: June 2012
• Source: University Hospital, Umeå
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 2002
• Est. primary completion date: February 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Procedure:
• Bronchoscopy
Bronchoscopy with endobronchial biopsy sampling and bronchoalveolar lavage (BAL) 18 hours post exposure. Airway inflammation was assessed.

Locations

Country	Name	City	State
Sweden	Department of Public Health and Clinical Medicine, Division of medicine, Pulmonary medicine	Umeå	Sverige

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Umeå	King's College London

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

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. doi: 10.1136/thx.2010.140053. Epub 2010 Sep 13. — View Citation

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. — View Citation

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. doi: 10.1164/rccm.200906-0858OC. Epub 2009 Dec 3. — View Citation

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. doi: 10.1164/rccm.200701-036OC. Epub 2008 Mar 12. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No