Severe Persistent AsthmaNCT02659618
Identification of Serum Biomarkers for CD15+ Hypodense Neutrophils in Severe Asthma
An observational study of Severe Persistent Asthma, run by Rush University Medical Center at 1 site in United States.
Trial summary
The goal of this study is to identify a serum biomarker(s) that can detect increased levels of a population of CD15+ hypodense neutrophils termed low-density granulocytes (LDG) in the blood of patients with severe persistent asthma. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Severe Persistent Asthma
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 16 Dec 2020
- 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Thirty prospective subjects will be screened to identify 20 subjects with severe persistent asthma. These subjects will be recruited from the Allergy/Immunology outpatient clinic at Rush University Medical Center along with self-referral through advertising posted on campus.
Who may be able to join
- Physician diagnosis of severe persistent asthma;
- Positive skin test or radioallergosorbent test (RAST) for an aeroallergen;
- Male or female age 12-65 years;
- Non-smoker.
Who cannot join
- Asthma exacerbation requiring treatment with or increase in oral corticosteroids within 30 days prior to the study;
- Respiratory infection within 30 days prior to the study;
- Starting or requiring a change in allergen immunotherapy within 30 days prior to the study;
- Having been treated with Xolair within the past year;
- Requiring chronic immunosuppressive therapy;
- Having taken methotrexate, gold salts, cyclosporine, or macrolide antibiotics within 3 months prior to study;
Show all 9Show fewer
- Having taken an investigational drug within 30 days prior to the study;
- Have a history of drug or alcohol abuse;
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University Consultants in Allergy/Immunology
Chicago, Illinois, 60612
About this study
The goal of this study is to identify a serum biomarker(s) that can detect increased levels of a population of CD15+ hypodense neutrophils termed low-density granulocytes (LDG) in the blood of patients with severe persistent asthma.
Read the detailed description
Neutrophils are implicated in the pathophysiology of multiple asthma phenotypes. It was shown in study IST Q4935s that low-density granulocytes (LDG) are elevated in the blood of patients with moderate or severe asthma. The greatest frequency and the highest percentages of LDG were observed in subjects with severe asthma. The LDG, which were first identified and characterized in systemic lupus erythematosus (SLE) patients, have been reported to display increased cytotoxicity for endothelial cells, increased tendency to form neutrophil extracellular traps, and increased production of tumor necrosis factor (TNF). It was also observed that the LDG expressed increased levels of CD15, which can facilitate attachment of activated platelets to the LDG. Identification of a putative serum biomarker that correlates with increased levels of the CD15+ LDG may be useful for the detection of neutrophil-associated inflammation in severe asthma.
Thirty subjects will be screened to identify 20 subjects with severe persistent asthma. The following data and/or samples will then be obtained within three weeks of the clinical assessment: (1) the percentages of LDG will be quantified by flow cytometry; (2) a blood sample will be collected into a PAXgene Blood tube and stored until shipped to Genentech for gene profiling analysis; and (3) a serum sample will be collected for measurement of total immunoglobulin E (IgE) and for future confirmation of potential biomarkers identified in the gene profiling analyses.
- Conditions
- Severe Persistent 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 |
|---|---|---|
| Severe Persistent Asthma | All subjects will have severe persistent asthma diagnosed by a doctor. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of low density granulocytes (LDG) in the peripheral blood mononuclear cell (PBMC)
Measured: Visit 1 day
mRNA levels in severe asthmatics as analyzed by gene profiling analysis
Messenger ribonucleic acid (mRNA) expression levels for blood leukocyte proteins.
Measured: Visit 1 day
Secondary outcomes (2)
Number of Participants with elevated LDG levels in severe asthmatics using gene profiling analysis on a single PAXgene tube sample
Measured: Visit 1 day
Serum samples will be collected and analyzed for measurement of total IgE
Correlation between LDG in severe asthma and biomarkers identified in gene profiling analysis
Measured: Visit 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startApr 2016
- Primary completion26 Sep 2018
- Study completion16 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Persistent 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Mary Tobin, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659618
- Sponsor's protocol ID
- ML29345
- Status last verified
- Dec 2020
- First submitted
- 6 Jul 2015
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Serum Biomarkers for CD15+ Hypodense Neutrophils in Severe Asthma
- ClinicalTrials.gov ID
- NCT02659618
- Acronym / sponsor ID
- ML29345
- Conditions
- Severe Persistent Asthma
- Keywords
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Apr 2016 (actual)
- Primary completion
- 26 Sep 2018 (actual)
- Study completion
- 16 Dec 2020 (actual)
- First posted
- 20 Jan 2016 (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 goal of this study is to identify a serum biomarker(s) that can detect increased levels of a population of CD15+ hypodense neutrophils termed low-density granulocytes (LDG) in the blood of patients with severe persistent asthma.
Detailed description
Neutrophils are implicated in the pathophysiology of multiple asthma phenotypes. It was shown in study IST Q4935s that low-density granulocytes (LDG) are elevated in the blood of patients with moderate or severe asthma. The greatest frequency and the highest percentages of LDG were observed in subjects with severe asthma. The LDG, which were first identified and characterized in systemic lupus erythematosus (SLE) patients, have been reported to display increased cytotoxicity for endothelial cells, increased tendency to form neutrophil extracellular traps, and increased production of tumor necrosis factor (TNF). It was also observed that the LDG expressed increased levels of CD15, which can facilitate attachment of activated platelets to the LDG. Identification of a putative serum biomarker that correlates with increased levels of the CD15+ LDG may be useful for the detection of neutrophil-associated inflammation in severe asthma.
Thirty subjects will be screened to identify 20 subjects with severe persistent asthma. The following data and/or samples will then be obtained within three weeks of the clinical assessment: (1) the percentages of LDG will be quantified by flow cytometry; (2) a blood sample will be collected into a PAXgene Blood tube and stored until shipped to Genentech for gene profiling analysis; and (3) a serum sample will be collected for measurement of total immunoglobulin E (IgE) and for future confirmation of potential biomarkers identified in the gene profiling analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe Persistent Asthma | – | –All subjects will have severe persistent asthma diagnosed by a doctor. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Thirty prospective subjects will be screened to identify 20 subjects with severe persistent asthma. These subjects will be recruited from the Allergy/Immunology outpatient clinic at Rush University Medical Center along with self-referral through advertising posted on campus.
Key inclusion criteria (4 listed)
- Physician diagnosis of severe persistent asthma;
- Positive skin test or radioallergosorbent test (RAST) for an aeroallergen;
- Male or female age 12-65 years;
- Non-smoker.
Key exclusion criteria (9 listed)
- Asthma exacerbation requiring treatment with or increase in oral corticosteroids within 30 days prior to the study;
- Respiratory infection within 30 days prior to the study;
- Starting or requiring a change in allergen immunotherapy within 30 days prior to the study;
- Having been treated with Xolair within the past year;
- Requiring chronic immunosuppressive therapy;
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
Percentage of low density granulocytes (LDG) in the peripheral blood mononuclear cell (PBMC)
Time frame: Visit 1 day
mRNA levels in severe asthmatics as analyzed by gene profiling analysis
Time frame: Visit 1 day
Messenger ribonucleic acid (mRNA) expression levels for blood leukocyte proteins.
2 secondary outcomes
Number of Participants with elevated LDG levels in severe asthmatics using gene profiling analysis on a single PAXgene tube sample
Time frame: Visit 1 day
Serum samples will be collected and analyzed for measurement of total IgE
Time frame: Visit 1 day
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 11 Feb 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Severe Persistent 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 9 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 11 Feb 2022. 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?
Percentage of low density granulocytes (LDG) in the peripheral blood mononuclear cell (PBMC) (time frame: Visit 1 day). The study lists 2 primary outcomes in all. 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 11 Feb 2022.