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

This study has been completed.
Sponsor:
Collaborator:
King's College London
Information provided by (Responsible Party):
Dr Annelie F Behndig, MD PhD, University Hospital, Umeå
ClinicalTrials.gov Identifier:
NCT01617330
First received: June 5, 2012
Last updated: June 11, 2012
Last verified: June 2012
  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:


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
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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:
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 July 28, 2014