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

June 11, 2012 updated by: Dr Annelie F Behndig, MD PhD, University Hospital, Umeå

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Sverige
      • Umeå, Sverige, Sweden, SE-90185
        • Department of Public Health and Clinical Medicine, Division of medicine, Pulmonary medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • BAL
  • Particulate matter
  • Air pollution
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:
  • BAL
  • Particulate matter
  • Air pollution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 hours post exposure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Umeå

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Primary Completion (Actual)

February 1, 2002

Study Completion (Actual)

February 1, 2002

Study Registration Dates

First Submitted

June 5, 2012

First Submitted That Met QC Criteria

June 11, 2012

First Posted (Estimate)

June 12, 2012

Study Record Updates

Last Update Posted (Estimate)

June 12, 2012

Last Update Submitted That Met QC Criteria

June 11, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DALLER

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Allergic Rhinitis

Clinical Trials on Bronchoscopy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe