Healthy
Conditions
Keywords
healthy volunteers, aspirin, Normal healthy subjects
Brief summary
Hypothesis: Low dose aspirin does not change exhaled inflammatory breath mediators in normal subjects.
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
DRUGaspirin
81 mg orally daily for two weeks
Sponsors
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy adults
Exclusion criteria
* any underlying major medical conditions such as heart disease, hypertension, stroke, diabetes, bleeding disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Exhaled Inflammatory Mediator Levels | baseline and 6 months | Descriptive statistics |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aspirin Low dose daily aspirin in healthy volunteers for two weeks
aspirin : 81 mg orally daily for two weeks | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Aspirin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 26 years STANDARD_DEVIATION 2.94 |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Change in Exhaled Inflammatory Mediator Levels
Descriptive statistics
Time frame: baseline and 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Aspirin | Change in Exhaled Inflammatory Mediator Levels | 1.42 pg/mL |