AsthmaIL-C2NCT04384835
Analysis of Sexual Bias in Type 2 Innate Lymphoid Cells (ILC2) in Asthmatic Patients
An observational study of Asthma, run by University Hospital, Toulouse at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Asthma
- What is being tested?
- Blood sample collection (one tube) and Blood sample collection (five tubes)
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 8 Mar 2021to 12 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Asthma patients
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Sexual Bias in Type 2 Innate Lymphoid Cells (ILC2) in Asthmatic Patients: Role of Androgens
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.
Read the 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
- Being tested
- Blood sample collection (one tube), Blood sample collection (five tubes)
- Keywords
- allergy, type 2 innate lymphoid cells
- Medical subject headings
- Asthma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collection (one tube)Biological
Collection of one tube of 7.5 ml blood in addition to a blood sample made in clinical practice
Blood sample collection (five tubes)Biological
Collection of five tubes of 7.5 ml blood in addition to a blood sample made in clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Mild to moderate asthma | low or medium dose of inhaled steroids according to GINA guidelines Receives: Biological: Blood sample collection (one tube) | |
| Severe asthma | criteria described by the ATS / ERS guidelines (for the recruitment of severe patients) Receives: Biological: Blood sample collection (five tubes) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of circulating ILC2 between gender with asthma.
Estimation of the proportion of circulating ILC2 between males and females with asthma.
Measured: Day 1
Secondary outcomes (2)
Frequency of circulating ILC2 according to asthma severity.
Estimation of the proportion of circulating ILC2 between mild to moderate asthma patients and severe asthma patients.
Measured: Day 1
Comparison of the effect of (androgenic receptor) AR ligands in a culture of ILC2.
ILC2 purified form PBMC of asthmatic females will be expanded in vitro 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start8 Mar 2021
- Primary completion1 May 2022
- Study completion12 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Guilleminault, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384835
- Sponsor's protocol ID
- RC31/20/0007
- Acronym
- IL-C2
- Status last verified
- May 2023
- First submitted
- 6 Mar 2020
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Sexual Bias in Type 2 Innate Lymphoid Cells (ILC2) in Asthmatic Patients: Role of Androgens
- ClinicalTrials.gov ID
- NCT04384835
- Acronym / sponsor ID
- IL-C2 / RC31/20/0007
- Conditions
- Asthma
- Keywords
- allergy, type 2 innate lymphoid cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild to moderate asthma | – | Biological: Blood sample collection (one tube)low or medium dose of inhaled steroids according to GINA guidelines |
| Severe asthma | – | Biological: Blood sample collection (five tubes)criteria described by the ATS / ERS guidelines (for the recruitment of severe patients) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Asthma patients
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- Asthma exacerbations defined as oral corticosteroids related to worsening respiratory symptoms within the past 4 weeks
- Pregnant women
- Breastfeeding women
- Autoimmune diseases
- Androgen medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collection (one tube)Collection of one tube of 7.5 ml blood in addition to a blood sample made in clinical practice | Biological | Mild to moderate asthma |
| Blood sample collection (five tubes)Collection of five tubes of 7.5 ml blood in addition to a blood sample made in clinical practice | Biological | Severe asthma |
Primary outcome
Frequency of circulating ILC2 between gender with asthma.
Time frame: Day 1
Estimation of the proportion of circulating ILC2 between males and females with asthma.
2 secondary outcomes
Frequency of circulating ILC2 according to asthma severity.
Time frame: Day 1
Comparison of the effect of (androgenic receptor) AR ligands in a culture of ILC2.
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Guilleminault, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of circulating ILC2 between gender with asthma. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.