Role of Circulating Innate Lymphoid Cells in Allergic Disorders

NCT ID: NCT03069495

Last Updated: 2023-08-28

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 18 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-21
• Study Completion Date: 2020-02-24

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.

Conditions

Allergy; Asthma; Urticaria

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Healthy Control Adult Subjects

Healthy adult subjects between the ages of 19-50 years will be enrolled.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jill A Poole, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

0197-17-EP

Identifier Type: -

Identifier Source: org_study_id