NCT01699204

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
Last Updated

September 29, 2017

Status Verified

September 1, 2017

Enrollment Period

4.1 years

First QC Date

October 1, 2012

Last Update Submit

September 27, 2017

Conditions

Asthma

Keywords

Air pollutionDiesel exhaustAirway responsivenessAsthmaAnti-oxidant

Outcome Measures

Primary Outcomes (1)

  • Human airway reactivity

    Establish that oxidative stress is responsible for changes in human airway reactivity induced by DE (300 µg/m3 inhaled for two hours).

    50 hours

Study Arms (3)

Filtered air with placebo

PLACEBO COMPARATOR

Exposure for 2 hours to filtered air and placebo tablets 3 times daily for 6 days

Other: Filtered air

Diesel exhaust with placebo

ACTIVE COMPARATOR

Exposure for 2 hours to diesel exhaust and placebo tablets 3 times daily for 6 days

Other: Diesel exhaust

Diesel exhaust with N-acetylcysteine

EXPERIMENTAL

Exposure for 2 hours to diesel exhaust and N-acetylcysteine tablets (600 mg) 3 times daily for 6 days

Dietary Supplement: N-acetylcysteineOther: Diesel exhaust

Interventions

N-acetylcysteineDIETARY_SUPPLEMENT

N-acetylcysteine 600mg taken orally 3 times daily for 6 days prior to exposure to diesel exhaust for 2 hours. The last supplement was taken the morning of the exposure

Diesel exhaust with N-acetylcysteine
Diesel exhaustOTHER

A placebo tablet taken 3 times daily for 6 days prior to exposure to diesel exhaust for 2 hours. The last supplement was taken the morning of the exposure

Diesel exhaust with N-acetylcysteineDiesel exhaust with placebo
Filtered airOTHER

A placebo tablet taken 3 times daily for 6 days prior to exposure to filtered air for 2 hours. The last supplement was taken the morning of the exposure

Filtered air with placebo

Eligibility Criteria

Age19 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V5Z1M9, Canada

Location

Related Publications (8)

  • Braman SS. The global burden of asthma. Chest. 2006 Jul;130(1 Suppl):4S-12S. doi: 10.1378/chest.130.1_suppl.4S.

    PMID: 16840363BACKGROUND

  • Atkinson RW, Anderson HR, Sunyer J, Ayres J, Baccini M, Vonk JM, Boumghar A, Forastiere F, Forsberg B, Touloumi G, Schwartz J, Katsouyanni K. Acute effects of particulate air pollution on respiratory admissions: results from APHEA 2 project. Air Pollution and Health: a European Approach. Am J Respir Crit Care Med. 2001 Nov 15;164(10 Pt 1):1860-6. doi: 10.1164/ajrccm.164.10.2010138.

    PMID: 11734437BACKGROUND

  • Janssen NA, Brunekreef B, van Vliet P, Aarts F, Meliefste K, Harssema H, Fischer P. The relationship between air pollution from heavy traffic and allergic sensitization, bronchial hyperresponsiveness, and respiratory symptoms in Dutch schoolchildren. Environ Health Perspect. 2003 Sep;111(12):1512-8. doi: 10.1289/ehp.6243.

    PMID: 12948892BACKGROUND

  • Mudway IS, Stenfors N, Duggan ST, Roxborough H, Zielinski H, Marklund SL, Blomberg A, Frew AJ, Sandstrom T, Kelly FJ. An in vitro and in vivo investigation of the effects of diesel exhaust on human airway lining fluid antioxidants. Arch Biochem Biophys. 2004 Mar 1;423(1):200-12. doi: 10.1016/j.abb.2003.12.018.

    PMID: 14871482BACKGROUND

  • Rudell B, Ledin MC, Hammarstrom U, Stjernberg N, Lundback B, Sandstrom T. Effects on symptoms and lung function in humans experimentally exposed to diesel exhaust. Occup Environ Med. 1996 Oct;53(10):658-62. doi: 10.1136/oem.53.10.658.

    PMID: 8943829BACKGROUND

  • Stenfors N, Nordenhall C, Salvi SS, Mudway I, Soderberg M, Blomberg A, Helleday R, Levin JO, Holgate ST, Kelly FJ, Frew AJ, Sandstrom T. Different airway inflammatory responses in asthmatic and healthy humans exposed to diesel. Eur Respir J. 2004 Jan;23(1):82-6. doi: 10.1183/09031936.03.00004603.

    PMID: 14738236BACKGROUND

  • Hashimoto S, Gon Y, Takeshita I, Matsumoto K, Jibiki I, Takizawa H, Kudoh S, Horie T. Diesel exhaust particles activate p38 MAP kinase to produce interleukin 8 and RANTES by human bronchial epithelial cells and N-acetylcysteine attenuates p38 MAP kinase activation. Am J Respir Crit Care Med. 2000 Jan;161(1):280-5. doi: 10.1164/ajrccm.161.1.9904110.

    PMID: 10619832BACKGROUND

  • McCreanor J, Cullinan P, Nieuwenhuijsen MJ, Stewart-Evans J, Malliarou E, Jarup L, Harrington R, Svartengren M, Han IK, Ohman-Strickland P, Chung KF, Zhang J. Respiratory effects of exposure to diesel traffic in persons with asthma. N Engl J Med. 2007 Dec 6;357(23):2348-58. doi: 10.1056/NEJMoa071535.

    PMID: 18057337BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

AcetylcysteineVehicle Emissions

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsComplex Mixtures

Study Officials

  • Christopher Carlsten, MD MPH

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 1, 2012

First Posted

October 3, 2012

Study Start

September 1, 2007

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

September 29, 2017

Record last verified: 2017-09

Locations

CA(1)