Role of Circulating Innate Lymphoid Cells in Allergic Disorders

NCT03069495 | Terminated

• 1 other identifier: 0197-17-EP
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergy; Asthma; Urticaria

Keywords

Allergy; Asthma; Urticaria

Outcome Measures

Primary Outcomes (1)

• ILC2 Phenotype

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

  52 weeks

Study Arms (3)

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.

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adult subjects age 19-50 years.

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Biospecimen

Retention: NONE RETAINED

A one time blood draw

MeSH Terms

Conditions

Hypersensitivity; Asthma; Urticaria

Condition Hierarchy (Ancestors)

Immune System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jill A Poole, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 3, 2017
• Study Start: August 21, 2017
• Primary Completion: February 24, 2020
• Study Completion: February 24, 2020
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)