Controlled Exposure to Diesel Exhaust in Subjects With Allergic Rhinitis

Not Applicable

Completed

• Conditions: Allergic Rhinitis
• Interventions: Procedure: Bronchoscopy

• Registration Number: NCT01617330
• Lead Sponsor: University Hospital, Umeå

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-03
• Primary Completion: 2002-02
• Study Completion: 2002-02
• Status Verified: 2012-06
• Study First Submitted: 2012-06-05
• Study First Submitted QC: 2012-06-11
• Last Update Submitted: 2012-06-11
• Study First Posted: 2012-06-12
• Last Update Posted: 2012-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Filtered air exposure	Bronchoscopy	2 hour exposure to filtered air during intermittent exercise
Diesel exhaust	Bronchoscopy	2 hour exposure to diesel exhaust at 100 microgram per cubic meter during intermittent exercise

Primary Outcome Measures

Name	Time	Method
Airway inflammation	18 hours post exposure	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.

Trial Locations

Locations (1)

Department of Public Health and Clinical Medicine, Division of medicine, Pulmonary medicine; 🇸🇪 Umeå, Sverige, Sweden