AllergyNCT03069495
Role of Circulating Innate Lymphoid Cells in Allergic Disorders
An observational study of Allergy and Asthma, run by University of Nebraska at 1 site in United States.
Trial summary
This study evaluates blood type 2 innate lymphoid cells in participants with mild to moderate asthma and participants with chronic urticaria as compared to healthy adult participants. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2017to 24 Feb 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 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adult subjects age 19-50 years.
Who may be able to join
- Adult subjects between age 19-50 years.
- Non-smokers, defined as < 100 cigarettes in lifetime.
Who cannot join
- Female donors will be excluded if they are menopausal or have undergone total abdominal hysterectomy and/or bilateral salpingoophorectomy
- For female donors, blood draw cannot occur during menstrual period time. Subjects will be excluded if they have menstrual period at timing of blood draw.
- Current and past smokers.
- Subjects with asthma and any other lung disease including chronic obstructive pulmonary disease, interstitial lung disease, pulmonary hypertension, sarcoidosis, cystic fibrosis.
- Pregnant or lactating subjects
- Subjects with hypercalcemia (> 10.3 mg/dL), renal insufficiency (glomerular filtration rate [GFR] < 50 mL/min/1.73m2), or malignancy.
Show all 9Show fewer
- Subjects with any symptoms of respiratory infection in the past 4 weeks.
- Subjects unable to hold leukotriene modifiers or antihistamines for at least 24 hours prior to blood draw.
- Subjects on any immunomodulators, including omalizumab, or systemic corticosteroid in the past 4 weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
This study evaluates blood type 2 innate lymphoid cells in participants with mild to moderate asthma and participants with chronic urticaria as compared to healthy adult participants.
Read the detailed description
The first objective of this study is to determine whether blood ILC2s differ in female vs. male allergic asthmatics. This is because females become more susceptible to asthma after puberty and experience more severe disease as adults.
The second objective of this study is to determine whether ILC2 cells in chronic urticaria differ from healthy controls.
There will be one shared healthy control adult subject group for comparison for objective 1 and 2.
In this study, there will be a blood draw once on 3 different adult populations aged 19-50 years: 1) Participants with mild-to moderate allergic asthma; 2) Participants with chronic urticaria, and 3) Healthy control adult participants. Demographics and allergy indicators will be collected from the medical chart. The investigators will acquire whole blood for serum and acquisition of specific lymphocyte populations. There will be no intervention or research follow up.
- Keywords
- Allergy, Asthma, Urticaria
- Medical subject headings
- Hypersensitivity, Asthma, Urticaria
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 |
|---|---|---|
| Healthy Control Adult Subjects | Healthy adult subjects between the ages of 19-50 years will be enrolled. | |
| Asthmatic Adult Subjects | Adult subjects between the ages of 19-50 years with mild-to-moderate asthma seen within the UNMC Allergy and Pulmonary Clinics will be invited to be enrolled. | |
| Chronic Urticaria Adult Subjects | Adult subjects between the ages of 19-50 years with chronic urticaria seen within the UNMC Allergy Clinics will be invited to be enrolled. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ILC2 Phenotype
Blood ILC2s responsiveness will be determined solely for research purposes using ex vivo stimulation assays.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start21 Aug 2017
- Primary completion24 Feb 2020
- Study completion24 Feb 2020
Why it stopped: Lack of research assistant to work on study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jill A Poole, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069495
- Sponsor's protocol ID
- 0197-17-EP
- Status last verified
- Aug 2023
- First submitted
- 22 Feb 2017
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Subject information will be de-identified. IPD will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Circulating Innate Lymphoid Cells in Allergic Disorders
- ClinicalTrials.gov ID
- NCT03069495
- Acronym / sponsor ID
- 0197-17-EP
- Keywords
- Allergy, Asthma, Urticaria
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of research assistant to work on study
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 24 Feb 2020 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 3 Mar 2017 (actual)
- 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.
This study evaluates blood type 2 innate lymphoid cells in participants with mild to moderate asthma and participants with chronic urticaria as compared to healthy adult participants.
Detailed description
The first objective of this study is to determine whether blood ILC2s differ in female vs. male allergic asthmatics. This is because females become more susceptible to asthma after puberty and experience more severe disease as adults.
The second objective of this study is to determine whether ILC2 cells in chronic urticaria differ from healthy controls.
There will be one shared healthy control adult subject group for comparison for objective 1 and 2.
In this study, there will be a blood draw once on 3 different adult populations aged 19-50 years: 1) Participants with mild-to moderate allergic asthma; 2) Participants with chronic urticaria, and 3) Healthy control adult participants. Demographics and allergy indicators will be collected from the medical chart. The investigators will acquire whole blood for serum and acquisition of specific lymphocyte populations. There will be no intervention or research follow up.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Control Adult Subjects | – | –Healthy adult subjects between the ages of 19-50 years will be enrolled. |
| Asthmatic Adult Subjects | – | –Adult subjects between the ages of 19-50 years with mild-to-moderate asthma seen within the UNMC Allergy and Pulmonary Clinics will be invited to be enrolled. |
| Chronic Urticaria Adult Subjects | – | –Adult subjects between the ages of 19-50 years with chronic urticaria seen within the UNMC Allergy Clinics will be invited to be enrolled. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adult subjects age 19-50 years.
Key inclusion criteria (2 listed)
- Adult subjects between age 19-50 years.
- Non-smokers, defined as < 100 cigarettes in lifetime.
Key exclusion criteria (9 listed)
- Female donors will be excluded if they are menopausal or have undergone total abdominal hysterectomy and/or bilateral salpingoophorectomy
- For female donors, blood draw cannot occur during menstrual period time. Subjects will be excluded if they have menstrual period at timing of blood draw.
- Current and past smokers.
- Subjects with asthma and any other lung disease including chronic obstructive pulmonary disease, interstitial lung disease, pulmonary hypertension, sarcoidosis, cystic fibrosis.
- Pregnant or lactating subjects
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
ILC2 Phenotype
Time frame: 52 weeks
Blood ILC2s responsiveness will be determined solely for research purposes using ex vivo stimulation assays.
Results and safety
The study was stopped early (reason given: Lack of research assistant to work on study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Individual participant dataSharing planned: No. Subject information will be de-identified. IPD will not be made available to other researchers.
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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.
Jill A Poole, MD principal investigator
University of Nebraska
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 Allergy and Asthma, run by University of Nebraska 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 2 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: stopped early, as of the sponsor's last update on 28 Aug 2023. 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 was stopped early (reason given: Lack of research assistant to work on study). Results are not available in the source record.
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?
ILC2 Phenotype (time frame: 52 weeks). 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 2023.