Longitudinal Acute Air Pollution Systemic Effects

NCT ID: NCT02677662

Last Updated: 2016-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-04-30

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.

Detailed Description

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Filtered air exposure

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

Group Type: SHAM_COMPARATOR

Filtered air

Intervention Type: OTHER

Filtered air

Diesel exhaust exposure

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

Group Type: EXPERIMENTAL

Diesel Exhaust

Intervention Type: OTHER

Dilute diesel exhaust

Interventions

Diesel Exhaust

Dilute diesel exhaust

Intervention Type: OTHER

Filtered air

Filtered air

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

King's College London

OTHER

Sponsor Role: collaborator

Umeå University

OTHER

Sponsor Role: lead

Responsible Party

Jenny Bosson

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jenny Bosson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Locations

Umeå University

Umeå, , Sweden

Countries

Sweden

Other Identifiers

2015-69-31M

Identifier Type: -

Identifier Source: org_study_id