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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elliot Israel, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00898222
First received: May 8, 2009
Last updated: October 29, 2014
Last verified: October 2014
  Purpose

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


Condition Intervention
Healthy
Drug: aspirin

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effect of Daily Low Dose Aspirin on Exhaled Inflammatory Mediators in Normal Subjects

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Change in Exhaled Inflammatory Mediator Levels [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Descriptive statistics


Enrollment: 4
Study Start Date: May 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aspirin
Low dose daily aspirin in healthy volunteers for two weeks
Drug: aspirin
81 mg orally daily for two weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy adults

Exclusion Criteria:

  • any underlying major medical conditions such as heart disease, hypertension, stroke, diabetes, bleeding disorders
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898222

Locations
United States, Massachusetts
Asthma Research Center, Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Shamsah Kazani, MD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Elliot Israel, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00898222     History of Changes
Other Study ID Numbers: ARC ASA Normal
Study First Received: May 8, 2009
Results First Received: July 16, 2014
Last Updated: October 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
healthy volunteers
aspirin
Normal healthy subjects

Additional relevant MeSH terms:
Aspirin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014