NCT00898222

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started May 2009

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

November 4, 2014

Completed
Last Updated

September 25, 2015

Status Verified

September 1, 2015

Enrollment Period

3 months

First QC Date

May 8, 2009

Results QC Date

July 16, 2014

Last Update Submit

September 21, 2015

Conditions

Healthy

Keywords

healthy volunteersaspirinNormal healthy subjects

Outcome Measures

Primary Outcomes (1)

  • Change in Exhaled Inflammatory Mediator Levels

    Descriptive statistics

    baseline and 6 months

Study Arms (1)

aspirin

EXPERIMENTAL

Low dose daily aspirin in healthy volunteers for two weeks

Drug: aspirin

Interventions

aspirinDRUG

81 mg orally daily for two weeks

aspirin

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy adults

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asthma Research Center, Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Dr. Shamsah Kazani
Organization
Brigham and Women's Hospital
skazani@partners.org
617-732-8201

Study Officials

  • Shamsah Kazani, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Elliot Israel, MD

Study Record Dates

First Submitted

May 8, 2009

First Posted

May 12, 2009

Study Start

May 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

September 25, 2015

Results First Posted

November 4, 2014

Record last verified: 2015-09

Locations

US(1)