Dose-dependent Effects of Second-hand Smoke on Vascular Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-07-31

Brief Summary

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The purpose of this study is to determine the vascular effects of brief second-hand smoke exposure on normal healthy individuals.

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Detailed Description

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Second-hand smoke remains a significant public health threat. Despite evidence to suggest that secondhand smoke contributes to adverse cardiovascular outcomes, little is known about the dose-dependent vascular effects of brief secondhand smoke exposure at low doses commonly encountered in the community. This study will investigate the acute vascular effects and dose-dependent biological mechanisms of secondhand smoke on endothelial function and oxidative stress.

Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Room air

Group Type PLACEBO_COMPARATOR

Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke

Intervention Type OTHER

acute one time exposure

Low dose exposure second-hand smoke

Group Type ACTIVE_COMPARATOR

Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke

Intervention Type OTHER

acute one time exposure

High dose exposure second-hand smoke

Group Type ACTIVE_COMPARATOR

Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke

Intervention Type OTHER

acute one time exposure

Interventions

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Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke

acute one time exposure

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy non-smoking adults

Exclusion Criteria

* Reported Active Smoking
* History of diabetes, hypertension, chronic respiratory disease, coronary artery disease, prior myocardial infarction or heart failure
* Pregnancy or breastfeeding
* Current use of prescription drugs within 14 days of trial
* Reported significant passive smoke exposure or elevated cotinine levels

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes