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Diesel Exhaust and Mechanism of Asthma

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University of British Columbia

Status

Completed

Conditions

Asthma

Treatments

Dietary Supplement: N-acetylcysteine
Other: Filtered air
Other: Diesel exhaust

Study type

Interventional

Funder types

Other

Identifiers

NCT01699204
H08-02288

Details and patient eligibility

About

This experiment is designed to test the hypothesis that oxidative stress is responsible for changes in airway responsiveness in humans exposed to diesel exhaust.

Full description

The specific aim is to test the hypothesis that diesel exhaust (DE) increases airway reactivity via oxidative stress, particularly in asthmatics. To test this hypothesis, we use a crossover in vivo experimental model in mild asthmatics and normal controls using a state-of-the-art diesel exhaust exposure facility.

Participants took N-acetylcysteine (600 mg) or placebo capsules three times daily for six days. On the final morning of supplementation, participants were exposed for 2 hours to either filtered air or diesel exhaust (300 µg·m-3 of particulate matter smaller than 2.5 microns). Twenty-six non-smokers between 19-49 years were studied under three experimental conditions (filtered air with placebo, diesel exhaust with placebo and diesel exhaust with N-acetylcysteine) using randomized, double-blind, crossover design, with a two week minimum washout between conditions. Methacholine challenge was performed pre-exposure (to determine baseline airway responsiveness) and post-exposure (to determine the effect of exposure).

Enrollment

26 patients

Sex

All

Ages

19 to 49 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Between 19-49 years, non smokers, asthmatics, healthy controls

Exclusion criteria

  • Smokers, pregnant or co-existing medical condition for which diesel exhaust would confer significant risk (i.e. coronary artery disease)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

26 participants in 3 patient groups, including a placebo group

Filtered air with placebo
Placebo Comparator group
Description:
Exposure for 2 hours to filtered air and placebo tablets 3 times daily for 6 days
Treatment:
Other: Filtered air
Diesel exhaust with placebo
Active Comparator group
Description:
Exposure for 2 hours to diesel exhaust and placebo tablets 3 times daily for 6 days
Treatment:
Other: Diesel exhaust
Diesel exhaust with N-acetylcysteine
Experimental group
Description:
Exposure for 2 hours to diesel exhaust and N-acetylcysteine tablets (600 mg) 3 times daily for 6 days
Treatment:
Dietary Supplement: N-acetylcysteine
Other: Diesel exhaust

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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