Role of Circulating Innate Lymphoid Cells in Allergic Dis... | NCT03069495

Studies
Role of Circulating Innate Lymphoid Cells in Allergic Disorders

NCT03069495

Sponsor

University of Nebraska

Status

Terminated

Last Update Posted

Aug 28, 2023Actual

Enrollment

18Actual

Phase

Not provided

Conditions

Allergy
Asthma
Urticaria

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of research assistant to work on study

Expanded Access Info

Start Date

Aug 21, 2017Actual

Primary Completion Date

Feb 24, 2020Actual

Completion Date

Feb 24, 2020Actual

First Submitted Date

Feb 22, 2017

First Submission Date that Met QC Criteria

Feb 27, 2017

First Posted Date

Mar 3, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2023

Last Update Posted Date

Aug 28, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ILC2 Phenotype	Blood ILC2s responsiveness will be determined solely for research purposes using ex vivo stimulation assays.	52 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Adult subjects age 19-50 years.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jill A Poole, MD	University of Nebraska	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Nebraska Medical Center		Omaha	Nebraska	68198	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Subject information will be de-identified. IPD will not be made available to other researchers.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006967	Hypersensitivity
D001249	Asthma
D014581	Urticaria

Ancestor Terms

ID	Term
D007154	Immune System Diseases
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive

Browse Leaves

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Browse Branches

Not provided