Longitudinal Acute Air Pollution Systemic Effects

Healthy Clinical Trial

— LAPSE  

Official title:

Longitudinal Acute Air Pollution Systemic Effects (LAPSE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02677662
• Other study ID #: 2015-69-31M
• Status: Completed
• Phase: N/A
• First received: January 21, 2016
• Last updated: May 11, 2016
• Start date: November 2015
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Diesel Exhaust
Dilute diesel exhaust
• Filtered air
Filtered air

Locations

Country	Name	City	State
Sweden	Umeå University	Umeå

Sponsors (2)

Lead Sponsor	Collaborator
Umeå University	King's College London

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory biomarkers	In blood samples (total and differential counts	72 hours	No
Secondary	Oxidative stress markers	In blood samples (ox-LDL, ROS)	72 hours	No
Secondary	Cardiovascular biomarkers	In blood samples (sTM, hsCRP, syndecan-1)	72 hours	No
Secondary	Metabolomics	Mass spectrometry based metabolomics in blood samples	72 hours	No