Face Masks to Reduce the Adverse Effects of Diesel Exhaust Inhalation

Healthy Clinical Trial

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Official title:

Face Masks to Reduce the Adverse Effects of Diesel Exhaust Inhalation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02729129
• Other study ID #: 14-12-31M
• Status: Completed
• Phase: N/A
• First received: March 18, 2016
• Last updated: April 6, 2016
• Start date: April 2014
• Est. completion date: February 2016

Study information

• Verified date: April 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 exposure is a major environmental and public health concern. The findings from controlled exposure studies have given biological plausibility to the epidemiological associations, and have defined important pathways that may be amenable to intervention. Ultimately, there is a need to address how one may protect the public from these detrimental effects. Two studies have been performed assessing the cardiovascular effects of wearing a face mask in a highly polluted urban area in China in healthy volunteers and patients with coronary heart disease. These demonstrated lower blood pressure and increased heart rate variability when wearing a face mask as compared to not. The investigators aim to test if wearing a highly efficient face mask during exposure to dilute diesel exhaust abrogates the well-known adverse cardiovascular effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy males

• Non-smoking

• All subjects undergo a general health examination and are required to have normal clinical examination, ECG, blood tests and lung function

Exclusion Criteria:

• Metabolic or cardiovascular disease

• Asthma or other respiratory disease

• Respiratory infection within 2 weeks of the study

• Antioxidant- and/or vitamin supplementation within 1 week prior to, as well as during the course of the study. (incl vitamin C, Acetylcysteine)

• Smokers or regular snus usage

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Diesel exhaust exposure with filtered facemask
1 hour exposure to dilute diesel exhaust (approximate particle matter concentration 300 mcg/m3) during intermittent exercise while wearing a filtered facemask.
• Diesel exhaust exposure with sham mask
1 hour exposure to dilute diesel exhaust (approximate particle matter concentration 300 mcg/m3) during intermittent exercise while wearing a sham facemask.

Locations

Country	Name	City	State
Sweden	Umeå University	Umeå

Sponsors (2)

Lead Sponsor	Collaborator
Umeå University	University of Edinburgh

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular vasomotor function	Forearm venous occlusion plethysmography to measure forearm blood flow during unilateral intrabrachial infusion of endothelial-dependent and -independent vasodilators. Assessment is shown in ml/100ml tissue/min.	2 hours	No
Secondary	Fibrinolytic function	Tissue plasminogen activator was analysed in blood samples taken after bradykinin infusions in order to assess fibrinolytic function (ng/ml).	2 hours	No
Secondary	Blood pressure	Ambulatory blood pressure monitors are worn by subjects for 24 hours during and after exposure.	24 hours	No
Secondary	Heart rate variability	Holter ECGs are worn by subjects during and for 24 hours post exposure. This will be assessed for heart rate variability (HRV).	24 hours	No