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

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Biological: ILC2 levels in blood

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 Type: Observational
• Enrollment (Actual): 36

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This case-control study compares cases (asthma patients) with healthy control subjects. Patients and controls are matched by sex and age (+- 5 years).

Description

Inclusion Criteria for Cases:

• The subject has given his/her informed consent and signed the consent form
• The subject is affiliated with or beneficiary of a medical insurance system
• The subject has had asthma for over a year
• The following are present in the patient's medical file: (i) a positive methacholine test (PC20 < 16 mg/ml) OR (ii) reversibility > 200 ml and 12% of the FEV1 after inhaling 400 µg or less of a short acting bronchodilator.
• Treatment with >= 1000 µg inhaled beclometasone equivalents

Exclusion Criteria for Cases:

• The subject is pregnant
• The subject is breastfeeding
• The subject is participating in another interventional study
• The subject has participated in another study in the 3 months preceding inclusion
• The subject is in an exclusion period determined by a previous study
• The subject is under judicial protection or is an adult under any kind of guardianship
• The subject refuses to sign the consent
• It is impossible to correctly inform the subject
• The subject cannot fluently read French
• Chronic respiratory disease present, known or suspected (other than asthma)
• Treated with Montelukast

Inclusion Criteria for Controls:

• The subject has given his/her informed consent and signed the consent form
• The subject is affiliated with or beneficiary of a medical insurance system

Exclusion Criteria for Controls:

• The subject is pregnant
• The subject is breastfeeding
• The subject is participating in another interventional study
• The subject has participated in another study in the 3 months preceding inclusion
• The subject is in an exclusion period determined by a previous study
• The subject is under judicial protection or is an adult under any kind of guardianship
• The subject refuses to sign the consent
• It is impossible to correctly inform the subject
• The subject cannot fluently read French
• Any kind of bronchial problem
• Smokers
• Chronic respiratory disease present, known or suspected
• Treated with Montelukast

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; Patients in this group are asthmatic (see inclusion/exclusion) criteria. Intervention: ILC2 levels in blood	Biological: ILC2 levels in blood; The levels of circulating ILC2 cells relative to other lymphocytes will be determined via flow cytometry
Controls; Controls are non-asthmatic subjects that are age and gender matched to asthma cases. Intervention: ILC2 levels in blood	Biological: ILC2 levels in blood; The levels of circulating ILC2 cells relative to other lymphocytes will be determined via flow cytometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% ILC2 cells among total blood lymphocytes	Determined by flow cytometry	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% ILC2 cells among total blood lymphocytes	Determined by flow cytometry; Asthma patients only.	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2014
• Primary Completion (Actual): April 14, 2015
• Study Completion (Actual): June 23, 2015

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 25, 2017

Study Record Updates

• Last Update Posted (Actual): May 1, 2017
• Last Update Submitted That Met QC Criteria: April 27, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 9243; 2013-A01443-42 (Other Identifier: RCB number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No