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Completed

NCT Number: NCT02677662

Longitudinal Acute Air Pollution Systemic Effects

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Umeå University

Umeå, 90187, Sweden

About this study

Exposure to air pollution (both indoor and outdoor sources) contributes to the premature deaths of 7 million people each year, primarily linked to cardiovascular and respiratory conditions. Within the complex mixture which air pollution comprises, combustion derived particulate matter (PM) has been suggested as one of the most harmful components to the cardiopulmonary system. In urban areas PM derived from combustion originates largely from diesel vehicles.

Numerous experimental chamber studies have demonstrated respiratory as well as cardiovascular dysfunctions after the inhalation of diesel exhaust. Many of these dysfunctions are driven by inflammation and oxidative stress. There is much less knowledge concerning the systemic effects of diesel exhaust exposure, and especially over longer time courses than 24 hours.

The investigators aim to investigate the time course of systemic effects (such as markers of inflammation, cardiovascular dysfunction, and oxidative stress) in blood and urine samples taken after a diesel exhaust exposure. The effects of exercise or rest in an experimental chamber exposure will also be investigated.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Diesel Exhaust

Other

Dilute diesel exhaust

Filtered Air

Other

Filtered air

Primary outcomes

  1. Inflammatory biomarkers

    Time frame: 72 hours

    In blood samples (total and differential counts

Secondary outcomes

  1. Oxidative stress markers

    Time frame: 72 hours

    In blood samples (ox-LDL, ROS)

  2. Cardiovascular biomarkers

    Time frame: 72 hours

    In blood samples (sTM, hsCRP, syndecan-1)

  3. Metabolomics

    Time frame: 72 hours

    Mass spectrometry based metabolomics in blood samples

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • King's College London

Registry information

Official study title

Longitudinal Acute Air Pollution Systemic Effects (LAPSE)

Acronym: LAPSE

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 9, 2016
Registry last updated
May 13, 2016

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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