HealthyNCT00898222
Effect of Daily Low Dose Aspirin on Exhaled Inflammatory Mediators in Normal Subjects
A study testing aspirin in people with Healthy, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Hypothesis: Low dose aspirin does not change exhaled inflammatory breath mediators in normal subjects. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Aug 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy adults
Who cannot join
- any underlying major medical conditions such as heart disease, hypertension, stroke, diabetes, bleeding disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Asthma Research Center, Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Hypothesis: Low dose aspirin does not change exhaled inflammatory breath mediators in normal subjects.
Read the detailed description
Aim:
- To study the effect of low dose aspirin on exhaled breath inflammatory mediators
- 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirinDrug
81 mg orally daily for two weeks
| Study group | Role | What they receive |
|---|---|---|
| aspirin | Experimental | Low dose daily aspirin in healthy volunteers for two weeks Receives: Drug: aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Exhaled Inflammatory Mediator Levels
Descriptive statistics
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startMay 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elliot Israel, MD, Brigham and Women's Hospital
- Investigators
- Shamsah Kazani, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898222
- Sponsor's protocol ID
- ARC ASA Normal
- Status last verified
- Sep 2015
- First submitted
- 8 May 2009
- Last updated
- 25 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Daily Low Dose Aspirin on Exhaled Inflammatory Mediators in Normal Subjects
- ClinicalTrials.gov ID
- NCT00898222
- Acronym / sponsor ID
- ARC ASA Normal
- Conditions
- Healthy
- Keywords
- healthy volunteers, aspirin, Normal healthy subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Posted 4 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis: Low dose aspirin does not change exhaled inflammatory breath mediators in normal subjects.
Detailed description
Aim:
- To study the effect of low dose aspirin on exhaled breath inflammatory mediators
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aspirin | Experimental | Drug: aspirinLow dose daily aspirin in healthy volunteers for two weeks |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy adults
Key exclusion criteria (1 listed)
- any underlying major medical conditions such as heart disease, hypertension, stroke, diabetes, bleeding disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aspirin81 mg orally daily for two weeks | Drug | aspirin |
Primary outcome
Change in Exhaled Inflammatory Mediator Levels
Time frame: baseline and 6 months
Descriptive statistics
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shamsah Kazani, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aspirin in people with Healthy, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Exhaled Inflammatory Mediator Levels (time frame: baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2015.