Severe AsthmaSevAsthmaNCT04680117
Defining the Severe Paediatric Asthma Endotype
A study testing Blood collection, Saliva sample and Nasal in people with Severe Asthma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The primary objective of this project is to extensively characterize the endotypes of pre-schoolers (0 to 6 years) and school-age children (6 to 12 years) with SA using an integrated approach, combining a description of their phenotype (asthma symptoms, atopy, and lung function) associated with histological (airway… Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Severe Asthma
- What is being tested?
- Blood collection, Saliva sample and Nasal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2021to 24 Apr 2025
- Phase
- Interventional
- 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 Up to 12 years
- All sexes
- No healthy volunteers
- Child
Patient Inclusion Criteria:
- Minors aged 0 to 6 years or 6 to 12 years, hospitalized for assessment of Severe Asthma
- Minors need with his follow-up an bronchial endoscopy with realization of LBA and biopsies of bronchial mucosa
- Social insurance affiliation, except AME
- Parents or legal guardians signed the Informed consent form
Control Inclusion Criteria:
- Minors aged 0 to 6 years or 6 to 12 years, hospitalized for assessment of severe respiratory syndrome except severe asthma
- Minors need with his follow-up an bronchial endoscopy with realization of LBA and biopsies of bronchial mucosa
- Social insurance affiliation, except AME
- Parents or legal guardians signed the Informed consent form
Patient Exclusion Criteria
- Prematurity (<37 weeks gestation)
- Broncho-pulmonary dysplasia, immune deficits, non-Severe Asthma bronchopathies, cystic fibrosis, heart disease, ongoing biotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Defining the Severe Paediatric Asthma Endotype: an Integrated Approach Combining Phenotypic Analyses Related to Immune, Metabolomics and Microbial Features
The primary objective of this project is to extensively characterize the endotypes of pre-schoolers (0 to 6 years) and school-age children (6 to 12 years) with SA using an integrated approach, combining a description of their phenotype (asthma symptoms, atopy, and lung function) associated with histological (airway inflammation and remodelling), immune (innate and adaptive immunity), metabolomics, and microbiota analyses. This goal shall be achieved by an unsupervised in-depth analysis of patients requiring bronchial endoscopy, with bronchial alveolar lavage (BAL) and bronchial biopsy, as part of their clinical assessment.
Read the detailed description
Asthma is a chronic disease affecting approximately 235 million people worldwide, and the number is rising. Asthma is not just a public health problem for developed countries; its incidence is also elevated in developing countries. Asthma concerns all age groups, but often starts in childhood. SA in children is infrequent, affecting 2-5% of the asthmatic paediatric population. Children with SA experience frequent SA attacks and have a reduced quality of life . They account for approximately half of the asthma healthcare costs. Asthma has long been thought to be a single disease but is now considered to encompass various conditions characterized by the same symptoms (wheeze, cough, shortness of breath, chest tightness), variable degrees of airflow limitation, and different pattern of inflammation. Recent studies highlighted the heterogeneity of asthma, and the potential influence of various pathogenic mechanisms, including airway inflammation, remodelling, and immune and metabolic pathways in a specific microbial environment. However, there is very little data concerning the pathological process, especially in children. Most of the data describing different asthma endotypes in children are derived from large observational prospective cohorts. Although very informative, these studies were designed to analyse a small number of easily measured parameters, mainly lung function and atopy. The complexity of asthma pathogenesis was therefore underestimated and the individuals' specificities only partially considered. In clinical practice, children with SA require an endoscopy, with broncho-alveolar lavage fluids (BALF) collection and bronchial biopsies to exclude a differential diagnosis and assess airway inflammation and remodelling. This approach also underestimates other components of the endotypes and results in "one size fits all" management based on high doses of inhaled steroids and the use of expensive biotherapy, such as anti-IgE therapy. Thus, although hospital admission and mortality ratesfor asthma decreased until the early 2000's, they have remained stable over the past 10 years. It is therefore imperative to develop new approaches that incorporate relevant parameters analysed in the airways. This project proposes an in-depth analysis, not only of clinical and functional parameters, but also of immune cells, metabolomic compounds, and microbiota present in the airways of asthmatic children.
The primary objective of the project is to extensively characterize the endotypes of pre-schoolers (0 to 6 years) and school-age children (6 to 12 years) with SA using an integrated approach, combining a description of their phenotype (asthma symptoms, atopy, and lung function) associated with histological (airway inflammation and remodelling), immune (innate and adaptive immunity), metabolomics, and microbiota analyses.
This goal shall be achieved by an unsupervised in-depth analysis of patients requiring bronchial endoscopy, with bronchial alveolar lavage (BAL) and bronchial biopsy, as part of their clinical assessment. The main hypothesis is that the complementarity of those approaches will allow investigators to delineate the immune and metabolic pathways and microbiota involved in children with SA. The secondary objectives are to: (1) cluster all data obtained to define new patient groups and develop biomarkers that summarise the different clusters; (2) determine the immune, metabolomic, and microbiota profile of these children to aid future fundamental research that will focus on dissecting new mechanisms involved in paediatric asthma; (3) determine whether pre-schoolers and school-age children with SA share common endotypic features; and (4) establish the basis for the prospective follow-up of patients to identify endotypes that predict asthma persistence throughout childhood, severity, and response to treatment.
- Conditions
- Severe Asthma
- Being tested
- Blood collection, Saliva sample, Nasal
- Keywords
- Asthma, Severe, Immunologic, Metabolomic, Microbiologic profil
- Medical subject headings
- Asthma, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionOther
Blood collection with samples of 15ml max by subject (case or control) at J0, M6 and M12:
- subject less than 5 kg : 1.8 to 4.5 ml max
- subject 5 kg to 10 kg : 4.5 to 9 ml max
- subject 10 kg to 15 kg : 9 to 13.5 ml
- subject 15 kg to 20 kg : 13.5 to 15 ml max
Saliva sampleOther
Saliva sample by subject at J0
NasalOther
Nasal brushing by subject at J0
| Study group | Role | What they receive |
|---|---|---|
| Cases with SA, classified by age group | Other | Patient hospitalized for assessment of severe asthma Receives: Other: Blood collection; Other: Saliva sample; Other: Nasal |
| Controls among children w/ SA: frequent&infrequent exacerbators | Other | Frequent exacerbators have 2 or more asthma severe exacerbations in the past years Receives: Other: Blood collection; Other: Saliva sample; Other: Nasal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the environment and smoke exposure
Environment Living in a urban or non-urban area : n (%) Visible mold/dampness at home: n (%) Pet ownership: : n (%) Smoke exposure : n (%) Presence of pets at home : n (%)
Measured: 1 day
Description of family atopy status
Atopy in 1 or 2 parents or siblings: n (%) Parental asthma : n (%) Parental atopic dermatitis: n (%) Parental immediate food allergy: n (%) Parental allergic rhinitis: n (%) Asthma in siblings: n (%) Atopic dermatitis in siblings: n (%) Immediate food allergy in siblings: n (%) Allergic rhinitis in siblings: n (%)
Measured: 1 day
Description of Demographics
Sex male or female: n (%) Age at inclusion: y Weight (kg) Height (m) Body mass index : calculated from weight and height Atopy : n (%) Total IgE : n (%)
- 1 positive allergy tests (SPT or sp IgE) to airborne allergens : n (%)
- 1 positive SPT or sp IgE to food allergen: n (%) History of food allergy: n (%) History of allergic rhinitis: n (%) History of atopic dermatitis: n (%) Symptomatic gastro-oesophageal reflux: n (%)
Measured: 1 day
Description of Asthma history in the past year
No of severe exacerbations : n
≥ 2 or 3 severe exacerbations: n (%) No. of cumulated days of oral steroids: n No. of emergency visits for acute asthma : n Asthma control ACT score : n
Measured: 1 day
Description of Lung function
Lung function FEV1 pre-BD (% predicted) FEV1 post-BD (% predicted) FEV1 pre-BD (Zscore) FEV1 post-BD (Zscore) FEV1/FVC pre-BD (%) FEV1/FVC post-BD (%) FEV1/FVC pre-BD (Zscore) FEV1/FVC post-BD (Zscore) Post BD FEV1 reversibility (%) No of patients with reversibility : n (%) FeNO (ppb) Asthma therapy ICS : (%) ICS doses : µg/day. eq Budesonide ICS + LABA : n (%) Leukotriene modifier : n (%) Maintenance oral corticosteroids: n (%) Immunotherapy: n (%) Omalizumab or biologics: n (%)
Measured: 1 day
Description of Asthma therapy
ICS : (%) ICS doses : µg/day. eq Budesonide ICS + LABA : n (%) Leukotriene modifier : n (%) Maintenance oral corticosteroids: n (%) Immunotherapy: n (%) Omalizumab or biologics: n (%)
Measured: 1 day
Description of Airway remodeling
reticular basement membrane thickness expressed in µm; airway smooth muscle area ; epithelial integrity; vessel number; mucus gland area
Measured: 1 day
Description of inflammatory and histological features in bronchoalveolar lavages (BAL)
Number of eosinophils, neutrophils, macrophages, basophils, lymphocytes expressed as percentage of total cells in BAL
Measured: 1 day
Description of inflammatory and histological features in bronchial mucosa
Number of eosinophils, neutrophils, macrophages, basophils, lymphocytes expressed per square millimeters of submucosal area
Measured: 1 day
Bronchial mucosa analysis
The number of IgE stained with anti-IgE Ab in the submucosa and the epithelium will be assessed and expressed per square millimeters of submucosal area The expression of cytokines in the mucosa will be assessed by multiplex and expressed in pg/ml or ng/ml.
Quantify by quantitative PCR mRNA encoding cytokines, chemokines and others immune activation markers as relative mRNA levels.
Measured: 1 day
BAL analysis
The number of mast cells, lymphocytes, innate lymphoid cells, mucosalassosiated invariant T (MAIT) cells, gammadelta T cells expressed as percentage of total cells in BAL, concentrations of Immunoglobulins G, E, M will be assessed and express in Ku/L The expression of cytokines will be assessed by multiplex and expressed in pg/ml or ng/ml.
Measured: 1 day
Blood analysis
Number of eosinophils, neutrophils, macrophages, basophils, lymphocytes, innate lymphoid cells expressed as percentage of total cells in blood; number of mucosal associated invariant T (MAIT) cells will be assessed and expressed as percentage of total cells and T cells in blood The number of invariant natural killer T cells will be assessed and expressed as percentage of total cells and T cells in blood The number of gammadelta T cells will be assessed and expressed as percentage of total cells and T cells in blood The concentrations of Immunoglobulins G, E, M will be assessed and express in Ku/L The expression of cytokines will be assessed by multiplex and expressed in pg/ml or ng/ml.
Measured: 1 day
Metabolomic signature
The global concentration of metabolites is first expressed as the signal intensity compared to internal controls. When metabolites are identified, they are quantified and their concentration expressed as pg/ml.
Measured: 1 day
Microbiota analysis
Quantify by quantitative PCR mRNA and DNA encoding as relative mRNA and DNA levels
Measured: 1 day
Secondary outcomes (9)
Cluster analysis
Identify the main phenotypes of severe asthma by the cluster analysis.
Measured: 1 year
Number of severe exacerbations in the 12 months following the inclusion
Patients will be then categorized in frequent exacerbators and non-frequent exacerbators (n) according to their number of severe exacerbations in the 12 months following inclusion
Measured: 1 year
Asthma Control Test (ACT) score 12 months after inclusion
from 0 to 27 (for children 4-11 years); from 5-25 for children 12 years and older - higher score is better control
Measured: 1 year
Asthma control 12 months after inclusion
according to international guidelines : not controlled, partially controlled, controlled
Measured: 1 year
Description of lung function 12 months after the inclusion
FEV1 pre-BD (% predicted); FEV1 post-BD (% predicted); FEV1 pre-BD (Zscore); FEV1 post-BD (Zscore); FEV1/FVC pre-BD (%); FEV1/FVC post-BD (%); FEV1/FVC pre-BD (Zscore); FEV1/FVC post-BD (Zscore); Post BD FEV1 reversibility (%); No of patients with reversibility : n (%); FeNO (ppb)
Measured: 1 year
Number of severe exacerbations during the 1 year follow up
Measured: 1 year
Number of emergency department visits for acute asthma during the 1 year follow up
Measured: 1 year
Number of cumulated days of oral steroids for asthma exacerbations during the 1 year follow up
Measured: 1 year
Number of hospital admissions for acute asthma during the 1 year follow up
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start15 Jun 2021
- Primary completion24 Apr 2025
- Study completion24 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe AsthmaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Guillaume Lezmi, Doctor (PHU), Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680117
- Sponsor's protocol ID
- APHP200135
- Other IDs
- 2020-A00248-31
- Acronym
- SevAsthma
- Status last verified
- Apr 2026
- First submitted
- 14 Sep 2020
- Last updated
- 6 May 2026
- 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 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Severe Paediatric Asthma Endotype: an Integrated Approach Combining Phenotypic Analyses Related to Immune, Metabolomics and Microbial Features
- ClinicalTrials.gov ID
- NCT04680117
- Acronym / sponsor ID
- SevAsthma / APHP200135
- Conditions
- Severe Asthma
- Keywords
- Asthma, Severe, Immunologic, Metabolomic, Microbiologic profil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 24 Apr 2025 (actual)
- First posted
- 22 Dec 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.
The primary objective of this project is to extensively characterize the endotypes of pre-schoolers (0 to 6 years) and school-age children (6 to 12 years) with SA using an integrated approach, combining a description of their phenotype (asthma symptoms, atopy, and lung function) associated with histological (airway inflammation and remodelling), immune (innate and adaptive immunity), metabolomics, and microbiota analyses. This goal shall be achieved by an unsupervised in-depth analysis of patients requiring bronchial endoscopy, with bronchial alveolar lavage (BAL) and bronchial biopsy, as part of their clinical assessment.
Detailed description
Asthma is a chronic disease affecting approximately 235 million people worldwide, and the number is rising. Asthma is not just a public health problem for developed countries; its incidence is also elevated in developing countries. Asthma concerns all age groups, but often starts in childhood. SA in children is infrequent, affecting 2-5% of the asthmatic paediatric population. Children with SA experience frequent SA attacks and have a reduced quality of life . They account for approximately half of the asthma healthcare costs. Asthma has long been thought to be a single disease but is now considered to encompass various conditions characterized by the same symptoms (wheeze, cough, shortness of breath, chest tightness), variable degrees of airflow limitation, and different pattern of inflammation. Recent studies highlighted the heterogeneity of asthma, and the potential influence of various pathogenic mechanisms, including airway inflammation, remodelling, and immune and metabolic pathways in a specific microbial environment. However, there is very little data concerning the pathological process, especially in children. Most of the data describing different asthma endotypes in children are derived from large observational prospective cohorts. Although very informative, these studies were designed to analyse a small number of easily measured parameters, mainly lung function and atopy. The complexity of asthma pathogenesis was therefore underestimated and the individuals' specificities only partially considered. In clinical practice, children with SA require an endoscopy, with broncho-alveolar lavage fluids (BALF) collection and bronchial biopsies to exclude a differential diagnosis and assess airway inflammation and remodelling. This approach also underestimates other components of the endotypes and results in "one size fits all" management based on high doses of inhaled steroids and the use of expensive biotherapy, such as anti-IgE therapy. Thus, although hospital admission and mortality ratesfor asthma decreased until the early 2000's, they have remained stable over the past 10 years. It is therefore imperative to develop new approaches that incorporate relevant parameters analysed in the airways. This project proposes an in-depth analysis, not only of clinical and functional parameters, but also of immune cells, metabolomic compounds, and microbiota present in the airways of asthmatic children.
The primary objective of the project is to extensively characterize the endotypes of pre-schoolers (0 to 6 years) and school-age children (6 to 12 years) with SA using an integrated approach, combining a description of their phenotype (asthma symptoms, atopy, and lung function) associated with histological (airway inflammation and remodelling), immune (innate and adaptive immunity), metabolomics, and microbiota analyses.
This goal shall be achieved by an unsupervised in-depth analysis of patients requiring bronchial endoscopy, with bronchial alveolar lavage (BAL) and bronchial biopsy, as part of their clinical assessment. The main hypothesis is that the complementarity of those approaches will allow investigators to delineate the immune and metabolic pathways and microbiota involved in children with SA. The secondary objectives are to: (1) cluster all data obtained to define new patient groups and develop biomarkers that summarise the different clusters; (2) determine the immune, metabolomic, and microbiota profile of these children to aid future fundamental research that will focus on dissecting new mechanisms involved in paediatric asthma; (3) determine whether pre-schoolers and school-age children with SA share common endotypic features; and (4) establish the basis for the prospective follow-up of patients to identify endotypes that predict asthma persistence throughout childhood, severity, and response to treatment.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases with SA, classified by age group | Other | Other: Blood collection, Other: Saliva sample, Other: NasalPatient hospitalized for assessment of severe asthma |
| Controls among children w/ SA: frequent&infrequent exacerbators | Other | Other: Blood collection, Other: Saliva sample, Other: NasalFrequent exacerbators have 2 or more asthma severe exacerbations in the past years |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 collectionBlood collection with samples of 15ml max by subject (case or control) at J0, M6 and M12: * subject less than 5 kg : 1.8 to 4.5 ml max * subject 5 kg to 10 kg : 4.5 to 9 ml max * subject 10 kg to 15 kg : 9 to 13.5 ml * subject 15 kg to 20 kg : 13.5 to 15 ml max | Other | Cases with SA, classified by age group, Controls among children w/ SA: frequent&infrequent exacerbators |
| Saliva sampleSaliva sample by subject at J0 | Other | Cases with SA, classified by age group, Controls among children w/ SA: frequent&infrequent exacerbators |
| NasalNasal brushing by subject at J0 | Other | Cases with SA, classified by age group, Controls among children w/ SA: frequent&infrequent exacerbators |
Primary outcome
Description of the environment and smoke exposure
Time frame: 1 day
Environment Living in a urban or non-urban area : n (%) Visible mold/dampness at home: n (%) Pet ownership: : n (%) Smoke exposure : n (%) Presence of pets at home : n (%)
Description of family atopy status
Time frame: 1 day
Atopy in 1 or 2 parents or siblings: n (%) Parental asthma : n (%) Parental atopic dermatitis: n (%) Parental immediate food allergy: n (%) Parental allergic rhinitis: n (%) Asthma in siblings: n (%) Atopic dermatitis in siblings: n (%) Immediate food allergy in siblings: n (%) Allergic rhinitis in siblings: n (%)
Description of Demographics
Time frame: 1 day
Sex male or female: n (%) Age at inclusion: y Weight (kg) Height (m) Body mass index : calculated from weight and height Atopy : n (%) Total IgE : n (%) * 1 positive allergy tests (SPT or sp IgE) to airborne allergens : n (%) * 1 positive SPT or sp IgE to food allergen: n (%) History of food allergy: n (%) History of allergic rhinitis: n (%) History of atopic dermatitis: n (%) Symptomatic gastro-oesophageal reflux: n (%)
Description of Asthma history in the past year
Time frame: 1 day
No of severe exacerbations : n ≥ 2 or 3 severe exacerbations: n (%) No. of cumulated days of oral steroids: n No. of emergency visits for acute asthma : n Asthma control ACT score : n
Description of Lung function
Time frame: 1 day
Lung function FEV1 pre-BD (% predicted) FEV1 post-BD (% predicted) FEV1 pre-BD (Zscore) FEV1 post-BD (Zscore) FEV1/FVC pre-BD (%) FEV1/FVC post-BD (%) FEV1/FVC pre-BD (Zscore) FEV1/FVC post-BD (Zscore) Post BD FEV1 reversibility (%) No of patients with reversibility : n (%) FeNO (ppb) Asthma therapy ICS : (%) ICS doses : µg/day. eq Budesonide ICS + LABA : n (%) Leukotriene modifier : n (%) Maintenance oral corticosteroids: n (%) Immunotherapy: n (%) Omalizumab or biologics: n (%)
Description of Asthma therapy
Time frame: 1 day
ICS : (%) ICS doses : µg/day. eq Budesonide ICS + LABA : n (%) Leukotriene modifier : n (%) Maintenance oral corticosteroids: n (%) Immunotherapy: n (%) Omalizumab or biologics: n (%)
Description of Airway remodeling
Time frame: 1 day
reticular basement membrane thickness expressed in µm; airway smooth muscle area ; epithelial integrity; vessel number; mucus gland area
Description of inflammatory and histological features in bronchoalveolar lavages (BAL)
Time frame: 1 day
Number of eosinophils, neutrophils, macrophages, basophils, lymphocytes expressed as percentage of total cells in BAL
Description of inflammatory and histological features in bronchial mucosa
Time frame: 1 day
Number of eosinophils, neutrophils, macrophages, basophils, lymphocytes expressed per square millimeters of submucosal area
Bronchial mucosa analysis
Time frame: 1 day
The number of IgE stained with anti-IgE Ab in the submucosa and the epithelium will be assessed and expressed per square millimeters of submucosal area The expression of cytokines in the mucosa will be assessed by multiplex and expressed in pg/ml or ng/ml. Quantify by quantitative PCR mRNA encoding cytokines, chemokines and others immune activation markers as relative mRNA levels.
BAL analysis
Time frame: 1 day
The number of mast cells, lymphocytes, innate lymphoid cells, mucosalassosiated invariant T (MAIT) cells, gammadelta T cells expressed as percentage of total cells in BAL, concentrations of Immunoglobulins G, E, M will be assessed and express in Ku/L The expression of cytokines will be assessed by multiplex and expressed in pg/ml or ng/ml.
Blood analysis
Time frame: 1 day
Number of eosinophils, neutrophils, macrophages, basophils, lymphocytes, innate lymphoid cells expressed as percentage of total cells in blood; number of mucosal associated invariant T (MAIT) cells will be assessed and expressed as percentage of total cells and T cells in blood The number of invariant natural killer T cells will be assessed and expressed as percentage of total cells and T cells in blood The number of gammadelta T cells will be assessed and expressed as percentage of total cells and T cells in blood The concentrations of Immunoglobulins G, E, M will be assessed and express in Ku/L The expression of cytokines will be assessed by multiplex and expressed in pg/ml or ng/ml.
Metabolomic signature
Time frame: 1 day
The global concentration of metabolites is first expressed as the signal intensity compared to internal controls. When metabolites are identified, they are quantified and their concentration expressed as pg/ml.
Microbiota analysis
Time frame: 1 day
Quantify by quantitative PCR mRNA and DNA encoding as relative mRNA and DNA levels
9 secondary outcomes
Cluster analysis
Time frame: 1 year
Number of severe exacerbations in the 12 months following the inclusion
Time frame: 1 year
Asthma Control Test (ACT) score 12 months after inclusion
Time frame: 1 year
Asthma control 12 months after inclusion
Time frame: 1 year
Description of lung function 12 months after the inclusion
Time frame: 1 year
Number of severe exacerbations during the 1 year follow up
Time frame: 1 year
Number of emergency department visits for acute asthma during the 1 year follow up
Time frame: 1 year
Number of cumulated days of oral steroids for asthma exacerbations during the 1 year follow up
Time frame: 1 year
Number of hospital admissions for acute asthma during the 1 year follow up
Time frame: 1 year
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 6 May 2026.
- 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.
Guillaume Lezmi, Doctor (PHU) principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood collection, Saliva sample and Nasal in people with Severe Asthma, run by Assistance Publique - Hôpitaux de Paris 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?
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 6 May 2026. 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?
Description of the environment and smoke exposure (time frame: 1 day). The study lists 14 primary outcomes in all. 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 6 May 2026.