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Completed

NCT Number: NCT01617330

Controlled Exposure to Diesel Exhaust in Subjects With Allergic Rhinitis

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.

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Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Umeå, Sverige, SE-90185, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bronchoscopy

Procedure

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

Other names: Particulate matter, Air pollution, BAL

Primary outcomes

  1. Airway inflammation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Umeå

Other

Collaborators

  • King's College London

Registry information

Acronym: DALLER

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
Jun 12, 2012
Registry last updated
Jun 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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