Effect of Daily Low Dose Aspirin on Exhaled Inflammatory Mediators in Normal Subjects

Overview

Hypothesis: Low dose aspirin does not change exhaled inflammatory breath mediators in normal subjects.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2009

Detailed Description

Aim: 1. To study the effect of low dose aspirin on exhaled breath inflammatory mediators 2. To compare the change to that seen in diseased states such as asthma and Lymphangioleiomyomatosis (LAM) We will interview healthy volunteers to confirm that they do not have any major underlying medical conditions such as heart disease, diabetes, stroke and bleeding disorders. We will collect breath condensate before and after two weeks of low dose over the counter enteric coated aspirin 81 mg/day therapy. Side effects are extremely rare at this dose, but include bleeding, heart burn and allergic reaction.

Interventions

  • Drug: aspirin
    • 81 mg orally daily for two weeks

Arms, Groups and Cohorts

  • Experimental: aspirin
    • Low dose daily aspirin in healthy volunteers for two weeks

Clinical Trial Outcome Measures

Primary Measures

  • Change in Exhaled Inflammatory Mediator Levels
    • Time Frame: baseline and 6 months
    • Descriptive statistics

Participating in This Clinical Trial

Inclusion Criteria

  • healthy adults Exclusion Criteria:

  • any underlying major medical conditions such as heart disease, hypertension, stroke, diabetes, bleeding disorders

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 95 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Brigham and Women’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Elliot Israel, MD, Elliot Israel, MD – Brigham and Women’s Hospital
  • Overall Official(s)
    • Shamsah Kazani, MD, Principal Investigator, Brigham and Women’s Hospital

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