Analysis of Sexual Bias in Type 2 Innate Lymphoid Cells (ILC2) in Asthmatic Patients

NCT ID: NCT04384835

Last Updated: 2023-06-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 34 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-08
• Study Completion Date: 2023-04-12

Brief Summary

Asthma is more common in females than in males but the difference has not been explained yet. Group 2 innate lymphoid cells (ILC2) have recently emerged as critical players in the initiation of allergic responses but their implications in the difference between males and females in terms of asthma prevalence has not been fully studied. The aim of this project is to compare the proportion of ILC2 in blood between males and females with asthma.

Detailed Description

Asthma is more common in males until puberty but becomes more prevalent and more severe in females after puberty suggesting a protective action of male sex hormones. ILC2 have recently emerged as critical players in the initiation of allergic responses. The present team established that androgens, signaling through the nuclear receptor 3 C4 (NR3C4) androgen receptor (AR), negatively control ILC2 at steady state and during lung inflammation. Relevant to this application, females with asthma have more circulating ILC2 than males. The present hypothesis is that harnessing AR signaling in ILC2 may provide a new therapeutic approach to down regulate tissue resident ILC2. This project will analyze the sex bias in circulating ILC2 in female and male patients with moderate to severe asthma. In females with asthma, the team will purify circulating ILC2 from peripheral blood mononuclear cells (PBMC) and expand them in vitro using cytokines and stromal cells in the presence of AR antagonist or agonist ligands. Bulk ILC2 cultures at day 7 will used to measure the expression profile of various gene, including AR.

Conditions

Asthma

Study Design

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

Study Groups

Mild to moderate asthma

low or medium dose of inhaled steroids according to GINA guidelines

Blood sample collection (one tube)

Intervention Type: BIOLOGICAL

Collection of one tube of 7.5 ml blood in addition to a blood sample made in clinical practice

Severe asthma

criteria described by the ATS / ERS guidelines (for the recruitment of severe patients)

Blood sample collection (five tubes)

Intervention Type: BIOLOGICAL

Collection of five tubes of 7.5 ml blood in addition to a blood sample made in clinical practice

Interventions

Blood sample collection (one tube)

Collection of one tube of 7.5 ml blood in addition to a blood sample made in clinical practice

Intervention Type: BIOLOGICAL

Blood sample collection (five tubes)

Collection of five tubes of 7.5 ml blood in addition to a blood sample made in clinical practice

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Asthma according to the criteria described by Global Initiative for Asthma (GINA) guidelines
• Severe asthma according to the criteria described by the American Thoracic Society (ATS) / European Respiratory Society (ERS) guidelines (for the recruitment of severe patients)
• Mild to moderate asthma based on low or medium dose of inhaled steroids according to GINA guidelines

Exclusion Criteria

• Asthma exacerbations defined as oral corticosteroids related to worsening respiratory symptoms within the past 4 weeks
• Pregnant women
• Breastfeeding women
• Autoimmune diseases
• Androgen medication
• Early menopause defined as the absence of menstruation for at least 1 year
• Body mass index ≥ 30 kg/m²
• Weight <40 kg
• Oral corticotherapy for more than 3 months
• Prediction of blood volume collected (care + research)> 80 ml or> 150 ml over a period of 30 days if blood collection within the past 30 days
• known anemia with hemoglobin <10 g/dl

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent Guilleminault, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Larrey hospital

Toulouse, , France

Countries

France

Other Identifiers

RC31/20/0007

Identifier Type: -

Identifier Source: org_study_id