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

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Bronchoscopy
Sponsored by
University Hospital, Umeå
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Allergic Rhinitis focused on measuring Particulate matter, Air pollution, Diesel exhaust, Allergic rhinitis

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Diesel exhaust

Filtered air exposure

Arm Description

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

2 hour exposure to filtered air during intermittent exercise

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 5, 2012
Last Updated
June 11, 2012
Sponsor
University Hospital, Umeå
Collaborators
King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT01617330
Brief Title
Controlled Exposure to Diesel Exhaust in Subjects With Allergic Rhinitis
Acronym
DALLER
Official Title
Controlled Exposure to Diesel Exhaust in Subjects With Allergic Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
February 2002 (Actual)
Study Completion Date
February 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Umeå
Collaborators
King's College London

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
Particulate matter, Air pollution, Diesel exhaust, Allergic rhinitis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diesel exhaust
Arm Type
Experimental
Arm Description
2 hour exposure to diesel exhaust at 100 microgram per cubic meter during intermittent exercise
Arm Title
Filtered air exposure
Arm Type
Experimental
Arm Description
2 hour exposure to filtered air during intermittent exercise
Intervention Type
Procedure
Intervention Name(s)
Bronchoscopy
Other Intervention Name(s)
Particulate matter, Air pollution, BAL
Intervention Description
Bronchoscopy with endobronchial biopsy sampling and bronchoalveolar lavage (BAL) 18 hours post exposure. Airway inflammation was assessed.
Primary Outcome Measure Information:
Title
Airway inflammation
Description
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.
Time Frame
18 hours post exposure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annelie F Behndig, MD PhD
Organizational Affiliation
Department of Public Health and Clinical Medicine, Division of medicine, Umeå University, Umeå
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Public Health and Clinical Medicine, Division of medicine, Pulmonary medicine
City
Umeå
State/Province
Sverige
ZIP/Postal Code
SE-90185
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
18337595
Citation
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.
Results Reference
background
PubMed Identifier
19965811
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.
Results Reference
background
PubMed Identifier
17877765
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. doi: 10.1111/j.1365-2222.2007.02823.x. Epub 2007 Sep 17.
Results Reference
background
PubMed Identifier
20837873
Citation
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.
Results Reference
background
PubMed Identifier
17456216
Citation
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.
Results Reference
result

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Controlled Exposure to Diesel Exhaust in Subjects With Allergic Rhinitis

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