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

NCT ID: NCT00898222

Last Updated: 2015-09-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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aspirin

Low dose daily aspirin in healthy volunteers for two weeks

Group Type EXPERIMENTAL

aspirin

Intervention Type DRUG

81 mg orally daily for two weeks

Interventions

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aspirin

81 mg orally daily for two weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy adults

Exclusion Criteria

* any underlying major medical conditions such as heart disease, hypertension, stroke, diabetes, bleeding disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Elliot Israel, MD

Elliot Israel, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shamsah Kazani, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Asthma Research Center, Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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ARC ASA Normal

Identifier Type: -

Identifier Source: org_study_id

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