NCT02677662

Brief Summary

Air pollution continues to be a key global issue with many governments focusing great attention on air quality legislation because of its harmful environmental and health impacts. Whilst there is much that remains unknown about the mechanisms underlying the negative health effects of air pollution, it is generally acknowledged that air pollution exposure leads to an increase in cardiovascular, cerebrovascular and respiratory mortality and morbidity. The current study will investigate systemic effects during a 72 hour period after a controlled diesel exhaust exposure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Nov 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

4 months

First QC Date

January 21, 2016

Last Update Submit

May 11, 2016

Conditions

Healthy

Keywords

Diesel exhaustOxidative stressSystemic inflammationAir pollution

Outcome Measures

Primary Outcomes (1)

  • Inflammatory biomarkers

    In blood samples (total and differential counts

    72 hours

Secondary Outcomes (3)

  • Oxidative stress markers

    72 hours

  • Cardiovascular biomarkers

    72 hours

  • Metabolomics

    72 hours

Study Arms (2)

Filtered air exposure

SHAM COMPARATOR

2 hour exposure to filtered air during intermittent exercise or rest.

Other: Filtered air

Diesel exhaust exposure

EXPERIMENTAL

2 hour exposure to dilute diesel exhaust (approximate PM10 (particulate matter\<10um) concentration 300 mcg/m3) during intermittent exercise or rest.

Other: Diesel Exhaust

Interventions

Diesel ExhaustOTHER

Dilute diesel exhaust

Diesel exhaust exposure
Filtered airOTHER

Filtered air

Filtered air exposure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Normal clinical examination
  • Normal EKG
  • Normal routine blood tests
  • Normal lung function
  • Normal skinprick test

You may not qualify if:

  • Cardiovascular disease
  • Diabetes Mellitus
  • Asthma and/or allergy
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umeå University

Umeå, 90187, Sweden

Location

MeSH Terms

Interventions

Vehicle Emissions

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

  • Jenny Bosson, MD, PhD

    Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 21, 2016

First Posted

February 9, 2016

Study Start

November 1, 2015

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

May 13, 2016

Record last verified: 2016-05

Locations

SE(1)