AsthmaNCT00700726
Cohort Study of the Patterns of Microvesicles in the Serum of Participants With Atopic and Non-atopic Asthma
An observational study of Asthma and Allergies, run by Ohio State University at 1 site in United States.
Trial summary
The purpose of this study is to determine if a simple blood test can help in disease management, particularly asthma. This will be researched by looking at certain features of the blood and to compare asthmatics without allergies to those that have allergy-induced asthma. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: primary care clinic
Who may be able to join
- be between the ages of 18 and 50.
- have diagnosed asthma.
- must have less "one pack per day for 10 years" smoking history
Who cannot join
- You have had a fever of 100.4º within 24 hours of Visit 2.
- You are enrolled in another interventional research trial.
- Have other major chronic illnesses that would interfere with participation in the study.
- You are pregnant.
- You chronically use oral corticosteroids.
- You have taken anti-coagulants, insulin, and any investigative drugs within 2 months.
Show all 12Show fewer
- You have the inability or unwillingness to provide consent.
- Inability to perform aerobic exercise.
- Inability to perform baseline measurements.
- Less than 80% completion of screening period diaries.
- Inability to be contacted by telephone.
- Intention to move out of the area within 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State Univeristy Medical Center
Columbus, Ohio, 43210
About this study
Official title: Study of the Patterns of Microvesicles in the Serum of Participants With Atopic and Non-atopic Asthma
The purpose of this study is to determine if a simple blood test can help in disease management, particularly asthma. This will be researched by looking at certain features of the blood and to compare asthmatics without allergies to those that have allergy-induced asthma.
Read the detailed description
A total of 20 participants (men or women) between the ages of 18-50 years with asthma will be enrolled. Participants will remain on their usual asthma treatments as prescribed by their usual asthma care provider. Current asthma treatments and any changes will be recorded at baseline and each subsequent visit. The primary outcome measures are correlation of microvesicle patterns with atopic state and variation from baseline with episodes of poor asthma control. Secondary outcomes include correlations between microvesicle patterns and spirometry, eNO levels, and glucorcorticoid sensitivity.
- Keywords
- blood test, asthma, skin test
- Medical subject headings
- Asthma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A. | participants with atopic and non-atopic asthma |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation of microvesicle patterns with atopic state and variation from baseline with episodes of poor asthma control
Measured: 6 months
Secondary outcomes (1)
correlations between microvesicle patterns and spirometry, eNO levels, and glucorcorticoid sensitivity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Mastronarde, MD, Ohio State University
- Investigators
- Clay M. Marsh, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700726
- Sponsor's protocol ID
- 2007H0102
- Status last verified
- Feb 2014
- First submitted
- 17 Jun 2008
- Last updated
- 13 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Patterns of Microvesicles in the Serum of Participants With Atopic and Non-atopic Asthma
- ClinicalTrials.gov ID
- NCT00700726
- Acronym / sponsor ID
- 2007H0102
- Keywords
- blood test, asthma, skin test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 19 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if a simple blood test can help in disease management, particularly asthma. This will be researched by looking at certain features of the blood and to compare asthmatics without allergies to those that have allergy-induced asthma.
Detailed description
A total of 20 participants (men or women) between the ages of 18-50 years with asthma will be enrolled. Participants will remain on their usual asthma treatments as prescribed by their usual asthma care provider. Current asthma treatments and any changes will be recorded at baseline and each subsequent visit. The primary outcome measures are correlation of microvesicle patterns with atopic state and variation from baseline with episodes of poor asthma control. Secondary outcomes include correlations between microvesicle patterns and spirometry, eNO levels, and glucorcorticoid sensitivity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A. | – | –participants with atopic and non-atopic asthma |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- primary care clinic
Key inclusion criteria (3 listed)
- be between the ages of 18 and 50.
- have diagnosed asthma.
- must have less "one pack per day for 10 years" smoking history
Key exclusion criteria (12 listed)
- You have had a fever of 100.4º within 24 hours of Visit 2.
- You are enrolled in another interventional research trial.
- Have other major chronic illnesses that would interfere with participation in the study.
- You are pregnant.
- You chronically use oral corticosteroids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
correlation of microvesicle patterns with atopic state and variation from baseline with episodes of poor asthma control
Time frame: 6 months
1 secondary outcome
correlations between microvesicle patterns and spirometry, eNO levels, and glucorcorticoid sensitivity
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2014.
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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.
Clay M. Marsh, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Allergies, run by Ohio State University 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 3 inclusion and 12 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 13 Feb 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
correlation of microvesicle patterns with atopic state and variation from baseline with episodes of poor asthma control (time frame: 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 13 Feb 2014.