Clinical trial NCT03069495: Role of Circulating Innate Lymphoid Cells in Allergic Disorders
Official title: Role of Circulating Innate Lymphoid Cells in Allergic Disorders
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Allergy
Asthma
Urticaria
Keywords: Allergy
Asthma
Urticaria
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects age 19-50 years.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

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.

Primary outcomes:
measure: ILC2 Phenotype
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Jill A Poole, MD
role: PRINCIPAL_INVESTIGATOR
References: