AsthmaNCT01224223
Myeloid Suppressors in Inflammation
An observational study of Asthma, run by University of South Florida at 1 site in United States.
Trial summary
Myeloid-derived suppressor cells (MDSC) have been studied for their ability to suppress T cell responses in vivo and in vitro. As a result, MDSC can regulate cellular responses to chronic inflammatory conditions such as cancer, leading to the induction of tolerance and, ultimately, tumor escape from immune… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jan 2012
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Ages eligible for study: 18 to 60 years Genders eligible for study: male and female Signed and dated written informed consent is obtained prior to study blood draw. Subjects being actively treated for chronic moderate to severe asthma based on National Heart Lung and Blood Institute guidelines (figure 1). Subjects must carry the diagnosis of asthma (made by a physician) for a minimum of six months. Subjects within the first seven days of an acute asthma exacerbation, as determined by the referring physician.Able to give informed consent.
Who may be able to join
- Ages eligible for study: 18 to 60 years
- Genders eligible for study: male and female
- Signed and dated written informed consent is obtained prior to study blood draw.
- Subjects being actively treated for chronic moderate to severe asthma based on National Heart Lung and Blood Institute guidelines (figure 1). Subjects must carry the diagnosis of asthma (made by a physician) for a minimum of six months.
- Subjects within the first seven days of an acute asthma exacerbation, as determined by the referring physician.
- Able to give informed consent.
Who cannot join
- Use of systemic corticosteroids within the previous two weeks.
- Pregnant and/or lactating females.
- Current tobacco use.
- Severe psychiatric illness.
- Current illicit substance abuse or dependence and/or abuse of alcohol.
- Current use of anti-microbial medications.
- Primary or secondary immunodeficiency.
- Any clinically significant uncontrolled medical condition that would put the patient's safety at risk.
Trial locations and contacts
1 site in 1 country.
United States1 site
USF Asthma, Allergy and Immunology CRU
Tampa, Florida, 33613
About this study
Myeloid-derived suppressor cells (MDSC) have been studied for their ability to suppress T cell responses in vivo and in vitro. As a result, MDSC can regulate cellular responses to chronic inflammatory conditions such as cancer, leading to the induction of tolerance and, ultimately, tumor escape from immune surveillance.
- Conditions
- Asthma
- Keywords
- asthma
- Medical subject headings
- Asthma
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 |
|---|---|---|
| acute asthma exaecerbtion patients | Patients experiencing acute exacerbation of their asthma | |
| chronic asthma group | Two groups are being enrolled. The first group is chronic asthma patients with FEV1 below 80% and FEV1/FVC ratio reduced by 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify and characterize specific cell types (human dendritic cells, myeloid-derived suppressor cells and T lymphocytes) that are present in acute and chronic asthma.
Measured: one year from start of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJan 2012
- Study completionJan 2012
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 University of South FloridaThe 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
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Lockey, University of South Florida
- Investigators
- Richard Lockey, MD, Principal investigator, USF Asthma, Allergy and Immunology CRU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224223
- Sponsor's protocol ID
- MYELOID
- Status last verified
- Oct 2010
- First submitted
- 18 Oct 2010
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myeloid Suppressors in Inflammation
- ClinicalTrials.gov ID
- NCT01224223
- Acronym / sponsor ID
- MYELOID
- Conditions
- Asthma
- Keywords
- asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 19 Oct 2010 (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.
Myeloid-derived suppressor cells (MDSC) have been studied for their ability to suppress T cell responses in vivo and in vitro. As a result, MDSC can regulate cellular responses to chronic inflammatory conditions such as cancer, leading to the induction of tolerance and, ultimately, tumor escape from immune surveillance.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acute asthma exaecerbtion patients | – | –Patients experiencing acute exacerbation of their asthma |
| chronic asthma group | – | –Two groups are being enrolled. The first group is chronic asthma patients with FEV1 below 80% and FEV1/FVC ratio reduced by 5% |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Ages eligible for study: 18 to 60 years Genders eligible for study: male and female Signed and dated written informed consent is obtained prior to study blood draw. Subjects being actively treated for chronic moderate to severe asthma based on National Heart Lung and Blood Institute guidelines (figure 1). Subjects must carry the diagnosis of asthma (made by a physician) for a minimum of six months. Subjects within the first seven days of an acute asthma exacerbation, as determined by the referring physician.Able to give informed consent.
Key inclusion criteria (6 listed)
- Ages eligible for study: 18 to 60 years
- Genders eligible for study: male and female
- Signed and dated written informed consent is obtained prior to study blood draw.
- Subjects being actively treated for chronic moderate to severe asthma based on National Heart Lung and Blood Institute guidelines (figure 1). Subjects must carry the diagnosis of asthma (made by a physician) for a minimum of six months.
- Subjects within the first seven days of an acute asthma exacerbation, as determined by the referring physician.
Key exclusion criteria (8 listed)
- Use of systemic corticosteroids within the previous two weeks.
- Pregnant and/or lactating females.
- Current tobacco use.
- Severe psychiatric illness.
- Current illicit substance abuse or dependence and/or abuse of alcohol.
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
To identify and characterize specific cell types (human dendritic cells, myeloid-derived suppressor cells and T lymphocytes) that are present in acute and chronic asthma.
Time frame: one year from start of study
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 28 Jun 2012.
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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.
Richard Lockey, MD principal investigator
USF Asthma, Allergy and Immunology CRU
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, run by University of South Florida 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 6 inclusion and 8 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 28 Jun 2012. 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?
To identify and characterize specific cell types (human dendritic cells, myeloid-derived suppressor cells and T lymphocytes) that are present in acute and chronic asthma. (time frame: one year from start of study). 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 28 Jun 2012.