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TerminatedNCT03069495Updated Aug 28, 2023

Role of Circulating Innate Lymphoid Cells in Allergic Disorders

An observational study in Allergy, Asthma and Urticaria, sponsored by University of Nebraska. Terminated at 1 site in United States. Open to participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-28.

Sponsored by University of Nebraska · Observational

Why this study was terminated
Lack of research assistant to work on study
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
18
Ages
19 Years to 50 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Allergy
  • Asthma
  • Urticaria

Keywords

  • Allergy
  • Asthma
  • Urticaria
03

In context

Urticaria

237 studies on the registry are indexed under Urticaria; 26 are open to participants now.

This study's enrollment of 18 is below the median of 162 across 52 observational studies indexed under Urticaria.

Browse Urticaria studies →

Lead sponsor

University of Nebraska is the lead sponsor of 473 studies on the registry; 66 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adult subjects age 19-50 years.

Inclusion criteria

  1. Adult subjects between age 19-50 years.
  2. Non-smokers, defined as \< 100 cigarettes in lifetime.

Exclusion criteria

Exclusion Criteria:

  1. Female donors will be excluded if they are menopausal or have undergone total abdominal hysterectomy and/or bilateral salpingoophorectomy
  2. 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.
  3. Current and past smokers.
  4. Subjects with asthma and any other lung disease including chronic obstructive pulmonary disease, interstitial lung disease, pulmonary hypertension, sarcoidosis, cystic fibrosis.
  5. Pregnant or lactating subjects
  6. Subjects with hypercalcemia (> 10.3 mg/dL), renal insufficiency (glomerular filtration rate [GFR] \< 50 mL/min/1.73m2), or malignancy.
  7. Subjects with any symptoms of respiratory infection in the past 4 weeks.
  8. Subjects unable to hold leukotriene modifiers or antihistamines for at least 24 hours prior to blood draw.
  9. Subjects on any immunomodulators, including omalizumab, or systemic corticosteroid in the past 4 weeks.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
18 participants (actual)
Patient registry
No
Biospecimen retention
None retained

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. ILC2 Phenotype

    Blood ILC2s responsiveness will be determined solely for research purposes using ex vivo stimulation assays.

    Time frame: 52 weeks

07

Study locations

1 site
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198, United States
08

References and documents

Individual participant data

Plan to share: No — Subject information will be de-identified. IPD will not be made available to other researchers.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03069495
Lead sponsor
University of Nebraska
Responsible party
Sponsor
First posted
Mar 3, 2017
Start date
Aug 21, 2017
Primary completion
Feb 24, 2020
Completion
Feb 24, 2020
Last update
Aug 28, 2023

Study contacts

Jill A Poole, MD
principal investigator · University of Nebraska

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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