Controlled Exposure to Diesel Exhaust in Subjects With Allergic Rhinitis

NCT ID: NCT01617330

Last Updated: 2012-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Study Completion Date

2002-02-28

Brief Summary

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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

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Diesel exhaust

2 hour exposure to diesel exhaust at 100 microgram per cubic meter during intermittent exercise

Group Type EXPERIMENTAL

Bronchoscopy

Intervention Type PROCEDURE

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

Filtered air exposure

2 hour exposure to filtered air during intermittent exercise

Group Type EXPERIMENTAL

Bronchoscopy

Intervention Type PROCEDURE

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

Interventions

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Bronchoscopy

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

Intervention Type PROCEDURE

Other Intervention Names

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Particulate matter Air pollution BAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College London

OTHER

Sponsor Role collaborator

University Hospital, Umeå

OTHER

Sponsor Role lead

Responsible Party

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Dr Annelie F Behndig, MD PhD

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Annelie F Behndig, MD PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Department of Public Health and Clinical Medicine, Division of medicine, Pulmonary medicine

Umeå, Sverige, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 18337595 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19965811 (View on PubMed)

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. doi: 10.1111/j.1365-2222.2007.02823.x. Epub 2007 Sep 17.

Reference Type BACKGROUND
PMID: 17877765 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20837873 (View on PubMed)

Brown 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.

Reference Type RESULT
PMID: 17456216 (View on PubMed)

Other Identifiers

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DALLER

Identifier Type: -

Identifier Source: org_study_id

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