Woodsmoke Exposure and Cardiovascular Function

Systemic Inflammation Clinical Trial

Official title:

Cardiovascular Effects of Experimental Exposure to Woodsmoke in Man

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01488500
• Other study ID #: WOODSMOKE II
• Status: Completed
• Phase: N/A
• First received: December 6, 2011
• Last updated: August 3, 2012
• Start date: November 2011
• Est. completion date: May 2012

Study information

• Verified date: August 2012
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

Air pollution is linked to respiratory and cardiovascular disease. Wood smoke is a common air in many parts of the world and previous studies indicate that wood smoke induce oxidative stress in the respiratory tract. It is not determined how different types of biomass combustion affect human health. In this study the investigators plan to investigate how inhalation of wood smoke and pellets smoke affect respiratory and cardiovascular health.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers

Exclusion Criteria:

• Use of regular medication except the oral contraceptive pill

• Current smokers

• Significant occupation exposure to air pollution

• Intercurrent illness

Study Design

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

Related Conditions & MeSH terms

• Inflammation
• Respiratory Inflammation
• Systemic Inflammation

Intervention

Other:
• Bronchoscopy
24 hours after exposure, a bronchoscopy will be performed to allow analysis of cells and inflammatory markers in bronchial wash, bronchioalveolar lavage and lung biopsies.

Locations

Country	Name	City	State
Sweden	Umeå University	Umeå

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory inflammation	Bronchoscopy will be performed, and samples collected by bronchoalveolar lavage and bronchial biopsy. Samples will be analysed for cell counts, histology and inflammatory markers.	24 hours after exposure to air or woodsmoke	No
Secondary	Central arterial stiffness	Central arterial stiffness will be measured at baseline and for the 1 hour following the exposure using the SphygmoCor and Vicorder devices	Baseline and for 1 hour after exposure	No
Secondary	Heart rate variability	Continuous electrocardiograms will be recorded using a holter monitor to determine heart rate variability	24 hours after the exposure	No
Secondary	Systemic inflammation	Blood samples will be taken at intervals following the exposure to woodsmoke to measure circulating inflammatory markers	24 hours after the exposure	No
Secondary	Lung function	Lung function will be assessed using spirometry before and after each exposure	Baseline and 24hrs after exposure	No