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

Asthma Clinical Trial

— ILC2-Asthma  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03128762
• Other study ID #: 9243
• Secondary ID: 2013-A01443-42
• Status: Completed
• Phase: N/A
• First received: April 20, 2017
• Last updated: April 27, 2017
• Start date: June 25, 2014
• Est. completion date: June 23, 2015

Study information

• Verified date: April 2017
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 23, 2015
• Est. primary completion date: April 14, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Biological:
• ILC2 levels in blood
The levels of circulating ILC2 cells relative to other lymphocytes will be determined via flow cytometry

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% ILC2 cells among total blood lymphocytes	Determined by flow cytometry	Day 0
Secondary	% ILC2 cells among total blood lymphocytes	Determined by flow cytometry; Asthma patients only.	6 months