Analysis of Sexual Bias in Type 2 Innate Lymphoid Cells (ILC2) in Asthmatic Patients
IL-C2
1 other identifier
observational
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2020
CompletedFirst Posted
Study publicly available on registry
May 12, 2020
CompletedStudy Start
First participant enrolled
March 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 12, 2023
CompletedJune 1, 2023
May 1, 2023
1.1 years
March 6, 2020
May 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of circulating ILC2 between gender with asthma.
Estimation of the proportion of circulating ILC2 between males and females with asthma.
Day 1
Secondary Outcomes (2)
Frequency of circulating ILC2 according to asthma severity.
Day 1
Comparison of the effect of (androgenic receptor) AR ligands in a culture of ILC2.
Day 1
Study Arms (2)
Mild to moderate asthma
low or medium dose of inhaled steroids according to GINA guidelines
Severe asthma
criteria described by the ATS / ERS guidelines (for the recruitment of severe patients)
Interventions
Collection of one tube of 7.5 ml blood in addition to a blood sample made in clinical practice
Collection of five tubes of 7.5 ml blood in addition to a blood sample made in clinical practice
Eligibility Criteria
Asthma patients
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Larrey hospital
Toulouse, 31059, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurent Guilleminault, MD
University Hospital, Toulouse
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2020
First Posted
May 12, 2020
Study Start
March 8, 2021
Primary Completion
May 1, 2022
Study Completion
April 12, 2023
Last Updated
June 1, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share