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

NCT ID: NCT03128762

Last Updated: 2017-05-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-06-25
• Study Completion Date: 2015-06-23

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

Conditions

Asthma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Cases

Patients in this group are asthmatic (see inclusion/exclusion) criteria.

Intervention: ILC2 levels in blood

ILC2 levels in blood

Intervention Type: BIOLOGICAL

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

ILC2 levels in blood

Intervention Type: BIOLOGICAL

The levels of circulating ILC2 cells relative to other lymphocytes will be determined via flow cytometry

Interventions

ILC2 levels in blood

The levels of circulating ILC2 cells relative to other lymphocytes will be determined via flow cytometry

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2013-A01443-42

Identifier Type: OTHER

Identifier Source: secondary_id

9243

Identifier Type: -

Identifier Source: org_study_id