Circulating Innate Lymphoid Cell Type 2 (ILC2) Levels and Asthma: a Case-control Study

Completed

• Conditions: Asthma
• Interventions: Biological: ILC2 levels in blood

• Registration Number: NCT03128762
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

The primary objective of this study is to demonstrate differences in ILC2 blood levels between asthma patients and control patients.

Detailed Description

The secondary objectives of this study are:

To show that ILC2 levels differ between asthma patients with a "TH2" (helper T cell type 2) profile and asthma patients with a "non-TH2" profile. A TH2 profile is defined as (for a given patient):

* circulating eosinophils \> 500 mm\^3 at least once during the year AND

* positive allergy skin or specific IgE (Immunoglobulin E) test AND

* induced sputum eosinophil level \>3% of leukocytes AND

* exhaled nitric oxide \> 25 ppb.

To study the variation in ILC2 levels over time among asthma patients who obtained a good level of control compared to other patients. A good level of control is defined as:

* no exacerbations during 6 months of followup (an exacerbation is defined as the un-planned need for care that modifies the patient's prescription for \>48h)

* FEV1 (forced expiratory volume in 1 second) value current / FEV1 best value \> 0.8

* symptom levels correspond to an ACQ (Asthma Control Questionnaire) questionnaire score of \< 0.75 over the last 7 days

Study Timeline

• Study Start: 2014-06-25
• Primary Completion: 2015-04-14
• Study Completion: 2015-06-23
• Status Verified: 2017-04
• Study First Submitted: 2017-04-20
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-25
• Last Update Submitted: 2017-04-27
• Last Update Posted: 2017-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	ILC2 levels in blood	Patients in this group are asthmatic (see inclusion/exclusion) criteria. Intervention: ILC2 levels in blood
Controls	ILC2 levels in blood	Controls are non-asthmatic subjects that are age and gender matched to asthma cases. Intervention: ILC2 levels in blood

Primary Outcome Measures

Name	Time	Method
% ILC2 cells among total blood lymphocytes	Day 0	Determined by flow cytometry

Secondary Outcome Measures

Name	Time	Method
% ILC2 cells among total blood lymphocytes	6 months	Determined by flow cytometry; Asthma patients only.