AsthmaNCT00968305
Interleukin (IL)-13 as a Marker in Pediatrics Asthma
An observational study of Asthma, run by Rush University Medical Center at 1 site in United States.
Trial summary
Asthma is a very common childhood chronic illness and is generally more severe in African Americans. The investigators attempted to determine whether a specific immune marker is associated with lung function and asthma severity. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Asthma
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Aug 2009
- 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 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: African-American children, ages 8 to 15 years, with clinically diagnosed asthma which had been stable for at least 4 weeks prior to enrollment in the study.
Who may be able to join
- African-American race, born in the U.S.
- Age 8-15 years
- Clinical diagnosis of asthma
- Subject is able to understand and follow verbal instructions in English
Who cannot join
- Asthma exacerbation in the 4 weeks preceding the research visit
- Oral/IV steroid use in the 4 weeks preceding the research visit
- Upper or lower respiratory tract infection in the 4 weeks preceding the research visit
- Antibiotic use in the 4 weeks preceding the research visit
- Use of a short-acting bronchodilator during the 6 hours prior to spirometry (lung function testing)
- Use of a long-acting bronchodilator during the 12 hours prior to spirometry (lung function testing)
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center; Clinic: University Consultants in Allergy and Immunology
Chicago, Illinois, 60612
About this study
Official title: Cytokine Production in Children With Asthma.
Asthma is a very common childhood chronic illness and is generally more severe in African Americans. The investigators attempted to determine whether a specific immune marker is associated with lung function and asthma severity.
Read the detailed description
This study examined the relationship between Interleukin (IL)-13 from phytohemagglutinin-activated polymorphonuclear blood cells and asthma severity, lung function (measured as FEV1%), and total serum IgE levels in African American children with clinically diagnosed asthma
- Conditions
- Asthma
- Keywords
- African American children with stable asthma, Asthma severity, Interleukin 13 from PHA stimulated PBMC, Lung function (FEV1%), Total serum IgE, Pediatrics
- 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 |
|---|---|---|
| Children with asthma | African American children with clinically diagnosed stable asthma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-13 from phytohemagglutinin activated peripheral blood mononuclear cells
Measured: 7 months (from the start to completion of study. The blood was drawn at the one and only visit for each subject)
Secondary outcomes (1)
Lung function measured by percent predicted forced expiratory volume in the first second (FEV1%)
Measured: 7 months (from the start to completion of study, but FEV1% was measured at the one and only visit for each subject)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startNov 2008
- Primary completionAug 2009
- Study completionAug 2009
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 Rush University Medical CenterThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Byung H Yu, MD, Principal investigator, Rush University Medical Center, Department of Immunology and Microbiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968305
- Sponsor's protocol ID
- L06121901
- Status last verified
- Aug 2009
- First submitted
- 19 Aug 2009
- Last updated
- 28 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokine Production in Children With Asthma.
- ClinicalTrials.gov ID
- NCT00968305
- Acronym / sponsor ID
- L06121901
- Conditions
- Asthma
- Keywords
- African American children with stable asthma, Asthma severity, Interleukin 13 from PHA stimulated PBMC, Lung function (FEV1%), Total serum IgE, Pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 28 Aug 2009 (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.
Asthma is a very common childhood chronic illness and is generally more severe in African Americans. The investigators attempted to determine whether a specific immune marker is associated with lung function and asthma severity.
Detailed description
This study examined the relationship between Interleukin (IL)-13 from phytohemagglutinin-activated polymorphonuclear blood cells and asthma severity, lung function (measured as FEV1%), and total serum IgE levels in African American children with clinically diagnosed asthma
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with asthma | – | –African American children with clinically diagnosed stable asthma |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- African-American children, ages 8 to 15 years, with clinically diagnosed asthma which had been stable for at least 4 weeks prior to enrollment in the study.
Key inclusion criteria (4 listed)
- African-American race, born in the U.S.
- Age 8-15 years
- Clinical diagnosis of asthma
- Subject is able to understand and follow verbal instructions in English
Key exclusion criteria (6 listed)
- Asthma exacerbation in the 4 weeks preceding the research visit
- Oral/IV steroid use in the 4 weeks preceding the research visit
- Upper or lower respiratory tract infection in the 4 weeks preceding the research visit
- Antibiotic use in the 4 weeks preceding the research visit
- Use of a short-acting bronchodilator during the 6 hours prior to spirometry (lung function testing)
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
Interleukin-13 from phytohemagglutinin activated peripheral blood mononuclear cells
Time frame: 7 months (from the start to completion of study. The blood was drawn at the one and only visit for each subject)
1 secondary outcome
Lung function measured by percent predicted forced expiratory volume in the first second (FEV1%)
Time frame: 7 months (from the start to completion of study, but FEV1% was measured at the one and only visit for each subject)
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 Aug 2009.
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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.
Byung H Yu, MD principal investigator
Rush University Medical Center, Department of Immunology and Microbiology
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 Rush University Medical Center 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 4 inclusion and 6 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 Aug 2009. 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?
Interleukin-13 from phytohemagglutinin activated peripheral blood mononuclear cells (time frame: 7 months (from the start to completion of study. The blood was drawn at the one and only visit for each subject)). 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 Aug 2009.