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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03128762
Acronym
ILC2-Asthma
Enrollment
36
Registered
2017-04-25
Start date
2014-06-25
Completion date
2015-06-23
Last updated
2017-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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

Interventions

BIOLOGICALILC2 levels in blood

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

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
% ILC2 cells among total blood lymphocytesDay 0Determined by flow cytometry

Secondary

MeasureTime frameDescription
% ILC2 cells among total blood lymphocytes6 monthsDetermined by flow cytometry; Asthma patients only.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026