AsthmaVIRASTHMA2NCT03960359
Inflammatory and Immune Profiles During a Severe Exacerbation in Preschool Asthmatic Children (<5 Years)
An observational study of Asthma, run by University Hospital, Lille.
Trial summary
Asthma/wheeze begins in the first years of life and is the most common chronic disease in preschool children (< 5 years). Different phenotypes have been suggested: Episodic-Viral Wheeze (EVW), absence of symptoms between exacerbations, among which Severe Intermittent Wheeze (SIW); and Multiple-trigger wheeze (MTW). Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Asthma
- What is being tested?
- Clinical, microbiological and inflammatory phenotype
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 24 Feb 2015to Feb 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Preschool asthmatic children hospitalized for a severe exacerbation (requiring a course of systemic steroids), in a pediatric ward of one of the hospitals involved in the study, in the Hauts-de-France Region, France.
Who may be able to join
- Preschool children aged 1 to < 5 years
- Asthmatic / recurrent wheezers (≥ 3 discrete exacerbations since birth and/or symptoms between exacerbations, according to the definition from the French HAS and GINA guidelines)
- Hospitalized (less than 3 days ago) for a severe exacerbation (requiring a course of oral steroids)
- In a pediatric ward participating in the study (Hospital centers of Lille, Arras, Bethune, Douai, Lens, Roubaix, Tourcoing, Armentieres, Seclin)
- Parental consent
Who cannot join
- History of chronic disease (other than asthma)
- History of preterm birth (inf 36 weeks of amenorrhea)
- Lack of understanding from the parents
About this study
Official title: Inflammatory and Immune Profiles at the Time of a Severe Exacerbation in Preschool Asthmatic Children (<5 Years), According to the Phenotype
Asthma/wheeze begins in the first years of life and is the most common chronic disease in preschool children (< 5 years).
Different phenotypes have been suggested: Episodic-Viral Wheeze (EVW), absence of symptoms between exacerbations, among which Severe Intermittent Wheeze (SIW); and Multiple-trigger wheeze (MTW). The determinants of these different clinical phenotypes and their evolution have been poorly studied.
The purpose of this study is to assess preschool wheezers at the time of a severe exacerbation: clinical features and biological determinants (virus/bacteria, molecules and cells involved in the inflammation) and at steady state (8 weeks later) and to follow them up until the age of 7. The investigators hypothesize that the nature of the inflammation at the time of the exacerbation is different between these clinical phenotypes and may be associated with different clinical and functional trajectories
Read the detailed description
Asthma/wheeze begins in the first years of life and is the most common chronic disease in preschool children (< 5 years).
Different phenotypes have been suggested: Episodic-Viral Wheeze (EVW): wheezing during discrete time periods (exacerbations), absence of symptoms between exacerbations; among which Severe Intermittent Wheeze (SIW): EVW with ≥ 2 exacerbations over the last 6 months; and Multiple-trigger wheeze (MTW): wheezing during exacerbations but also symptoms (cough, exercise-induced symptoms,…) between episodes. The determinants of these different clinical phenotypes and their evolution have been poorly studied.
The purpose of this study is to assess preschool asthmatic children at the time of a severe exacerbation: clinical features and biological determinants (virus/bacteria, molecules and cells involved in the inflammation) and at steady state (8 weeks later) and to follow them up until the age of 7. The investigators hypothesize that the nature of the inflammation at the time of the exacerbation is different between these clinical phenotypes and may be associated with different clinical and functional trajectories.
The primary objective is to compare levels of IFNg, IL-5, IL-13, IL-33, TSLP in blood and induced sputum between the 2 main phenotypes: EVW and MTW.
Preschool asthmatic children hospitalized for a severe exacerbation (requiring a course of systemic steroids) are included in a pediatric ward of one of the hospitals involved in the study, in the Hauts-de-France Region, France.
Clinical phenotype: temporal pattern of wheeze (EVW, SIW, MTW), history and clinical data, allergy diagnosis work-up Microbiological phenotype: viral status (PCR in nasal swab sample), bacteriological status (culture of induced sputum) Inflammatory phenotype: profile of cytokines, phenotype of immune cells in the blood and the sputum, cytokine response to TLR ligands by peripheral blood mononuclear cells will be assessed at the time of inclusion and at steady state 8 weeks later.
Children will be follow-up until the age of 7 (clinical data, control of asthma, lung function).
- Conditions
- Asthma
- Being tested
- Clinical, microbiological and inflammatory phenotype
- Keywords
- Asthma, wheeze, preschool, phenotype
- Medical subject headings
- Asthma, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical, microbiological and inflammatory phenotypeOther
Clinical phenotype: temporal pattern of wheeze (EVW, SIW, MTW), history and clinical data, allergy diagnosis work-up Microbiological phenotype: viral status (PCR in nasal swab sample), bacteriological status (culture of induced sputum) Inflammatory phenotype: profile of cytokines, phenotype of immune cells in the blood and the sputum, cytokine response to TLR ligands by peripheral blood mononuclear cells.
| Study group | Role | What they receive |
|---|---|---|
| Episodic viral wheezers (EVW) | EVW: Wheezing during discrete time periods (exacerbations), absence of symptoms between exacerbations Among which SIW: EVW with ≥ 2 exacerbations over the last 6 months Clinical, microbiological and inflammatory phenotype Receives: Other: Clinical, microbiological and inflammatory phenotype | |
| Multiple trigger wheezers (MTW) | MTW : wheezing during exacerbations but also symptoms between episodes. Clinical, microbiological and inflammatory phenotype Receives: Other: Clinical, microbiological and inflammatory phenotype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory profile at exacerbation
concentration levels of IFNg, IL-5, IL-13, IL-33, TSLP in blood and induced sputum (all concentrations expressed in pg/ml, obtained with multiplex assays) between wheeze patterns: EVW (among which SIW) vs MTW
Measured: At the time of the inclusion
Secondary outcomes (28)
Inflammatory profile at steady state
concentration levels of IFNg, IL-5, IL-13, IL-33, TSLP in blood and induced sputum (all concentrations expressed in pg/ml, obtained with multiplex assays) between wheeze patterns: EVW (among which SIW) vs MTW
Measured: at baseline: consult at least 8 weeks after exacerbation
Change of inflammatory profile between exacerbation and steady state
concentration levels of IFNg, IL-5, IL-13, IL-33, TSLP in blood and induced sputum (all concentrations expressed in pg/ml, obtained with multiplex assays) between wheeze patterns: EVW (among which SIW) vs MTW
Measured: At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation)
Levels of cytokines in blood
Concentration levels of cytokines (IL-4, IL-17A, IL-22, TNF-alpha, IL-1beta, IL-6, IL-10) in blood (all concentrations expressed in pg/ml, obtained with multiplex assays) between wheeze patterns: EVW (among which SIW) vs MTW
Measured: At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation)
Levels of cytokines in induced sputum
Concentration levels of cytokines (IL-4, IL-17A, IL-22, TNF-alpha, IL-1beta, IL-6, IL-10) in induced sputum (all concentrations expressed in pg/ml, obtained with multiplex assays) between wheeze patterns: EVW (among which SIW) vs MTW
Measured: At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation)
Levels of interferons in blood
Concentrations levels of interferons (IFN-beta, IL-29) in blood (all concentrations expressed in pg/ml, obtained with multiplex assays) between wheeze patterns: EVW (among which SIW) vs MTW
Measured: At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation)
Levels of interferons in induced sputum
Concentration levels of interferons (IFN-beta, IL-29) in induced sputum (all concentrations expressed in pg/ml, obtained with multiplex assays) between wheeze patterns: EVW (among which SIW) vs MTW
Measured: At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation)
Levels of chemokines in blood
Concentration levels of chemokines (CXCL8, CXCL10, CCL5, CCL20) in blood (all concentrations expressed in pg/ml, obtained with multiplex assays) between wheeze patterns: EVW (among which SIW) vs MTW
Measured: At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation)
Levels of chemokines in induced sputum
Concentration levels of chemokines (CXCL8, CXCL10, CCL5, CCL20) in induced sputum (all concentrations expressed in pg/ml, obtained with multiplex assays) between wheeze patterns: EVW (among which SIW) vs MTW
Measured: At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation)
Expression patterns of mononuclear cells
Percentage of mononuclear cells in peripheral blood and sputum (sorted by flow cytometry): lymphocytes, dendritic cells, innate lymphoid cells
Measured: At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation)
Percentage of patients with tobacco exposure
Percentage of tobacco exposure (qualitative data)
Measured: At the time of the inclusion
Percentage of patients with mould/moisture exposure
Percentage of visible mould/moisture exposure (qualitative data, based on declaration by the parents)
Measured: At the time of the inclusion
Percentage of patients with pet ownership
Percentage of pet ownership (qualitative data)
Measured: At the time of the inclusion
Percentage of patients living in urban area
Percentage of urban living (qualitative data)
Measured: At the time of the inclusion
number of asthma exacerbations in the previous year
number of asthma exacerbations in the previous year (quantitative data)
Measured: At the time of the inclusion
Percentage of patients with associated atopic diseases
Percentage of associated atopic disorders: atopic dermatitis, atopic rhinitis, food allergy (qualitative data)
Measured: At the time of the inclusion
Control of asthma
Control of asthma based on symptoms (breath, cough, breathlessness, impact on activity and social behavior) and previous exacerbations in the past year, and classified according to GINA criteria: well-controlled, partly controlled, uncontrolled (semi-quantitative)
Measured: At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation)
Features of the exacerbation: severity
Severity assessed during the first hour in the emergency department (before treatment), using PRAM severity score: mild asthma (0-3), moderate asthma (4-7), severe asthma (8-12) (quantitative data)
Measured: At the time of the inclusion
Features of the exacerbation: length
Length of stay and length of oxygen need (in days)
Measured: At the time of the inclusion
Atopy
Atopy: positivity of skin prick tests (≥ 3 mm diameter) and/or specific IgE (≥ 0,35 ku/l), mono or polysensitized status (qualitative data)
Measured: At the time of the inclusion and at the age of 7
Blood leukocyte count
Count of neutrophils and eosinophils (number/mm3)
Measured: At the time of the inclusion and at the age of 7
ImmunoCAP ISAC (Thermo Fisher Scientific)
Levels of component specific IgE antibodies will be expressed in ISAC standardized units (ISU). We will categorized the raw data into 4 sIgE semiquantitative discrete groups, according to the manufacturer's guidelines: no (<0.3 ISU), low (0.3-1 ISU), medium (1-15 ISU), and high (>15 ISU) sensitization
Measured: At the time of the inclusion and at the age of 7
Microbiological phenotype: viral status
Virus identification by PCR in nasal swab sample (qualitative data)
Measured: At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation)
Microbiological phenotype: bacteriological status
Positive identification of bacteria (positive if titer >= 10.4/ml) by culture of induced sputum (qualitative data)
Measured: At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation)
History at the age of 7
History of asthma exacerbations in the previous year, presence of other atopic diseases: atopic dermatitis, atopic rhinitis, food allergy (qualitative data)
Measured: At the age of 7
Control of asthma at the age of 7
Control of asthma based on symptoms (breath, cough, breathlessness, impact on activity and social behavior) and previous exacerbations in the past year, and classified according to GINA criteria: well-controlled, partly controlled, uncontrolled (semi-quantitative)
Measured: At the age of 7
Atopy at the age of 7
Atopy: positivity of skin prick tests (≥ 3 mm diameter) and/or specific IgE (≥ 0,35 ku/l), mono or polysensitized status (qualitative data)
Measured: At the age of 7
Lung function at the age of 7: forced expiratory volume in one second
Forced expiratory volume in one second (FEV1) after administration of short acting beta agonists, obtain with spirometry test (expressed in Z-score)
Measured: At the age of 7
Lung function at the age of 7 : forced vital capacity
Forced vital capacity (FVC) after administration of short acting beta agonists, obtain with spirometry test (expressed in Z-score)
Measured: At the age of 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start24 Feb 2015
- Primary completion12 Apr 2023
- Study completionFeb 2033 (estimated)
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, LilleThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Région Nord-Pas de Calais, France, Stallergenes Greer
- Responsible party
- Sponsor
- Investigators
- Antoine Deschildre, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960359
- Sponsor's protocol ID
- 2014_20
- Other IDs
- 2014-A01687-40
- Acronym
- VIRASTHMA2
- Status last verified
- Dec 2025
- First submitted
- 17 Jan 2019
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory and Immune Profiles at the Time of a Severe Exacerbation in Preschool Asthmatic Children (<5 Years), According to the Phenotype
- ClinicalTrials.gov ID
- NCT03960359
- Acronym / sponsor ID
- VIRASTHMA2 / 2014_20
- Conditions
- Asthma
- Keywords
- Asthma, wheeze, preschool, phenotype
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Région Nord-Pas de Calais, France, Stallergenes Greer
- Study start
- 24 Feb 2015 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- Feb 2033 (estimated)
- First posted
- 23 May 2019 (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/wheeze begins in the first years of life and is the most common chronic disease in preschool children (< 5 years).
Different phenotypes have been suggested: Episodic-Viral Wheeze (EVW), absence of symptoms between exacerbations, among which Severe Intermittent Wheeze (SIW); and Multiple-trigger wheeze (MTW). The determinants of these different clinical phenotypes and their evolution have been poorly studied.
The purpose of this study is to assess preschool wheezers at the time of a severe exacerbation: clinical features and biological determinants (virus/bacteria, molecules and cells involved in the inflammation) and at steady state (8 weeks later) and to follow them up until the age of 7. The investigators hypothesize that the nature of the inflammation at the time of the exacerbation is different between these clinical phenotypes and may be associated with different clinical and functional trajectories
Detailed description
Asthma/wheeze begins in the first years of life and is the most common chronic disease in preschool children (< 5 years).
Different phenotypes have been suggested: Episodic-Viral Wheeze (EVW): wheezing during discrete time periods (exacerbations), absence of symptoms between exacerbations; among which Severe Intermittent Wheeze (SIW): EVW with ≥ 2 exacerbations over the last 6 months; and Multiple-trigger wheeze (MTW): wheezing during exacerbations but also symptoms (cough, exercise-induced symptoms,…) between episodes. The determinants of these different clinical phenotypes and their evolution have been poorly studied.
The purpose of this study is to assess preschool asthmatic children at the time of a severe exacerbation: clinical features and biological determinants (virus/bacteria, molecules and cells involved in the inflammation) and at steady state (8 weeks later) and to follow them up until the age of 7. The investigators hypothesize that the nature of the inflammation at the time of the exacerbation is different between these clinical phenotypes and may be associated with different clinical and functional trajectories.
The primary objective is to compare levels of IFNg, IL-5, IL-13, IL-33, TSLP in blood and induced sputum between the 2 main phenotypes: EVW and MTW.
Preschool asthmatic children hospitalized for a severe exacerbation (requiring a course of systemic steroids) are included in a pediatric ward of one of the hospitals involved in the study, in the Hauts-de-France Region, France.
Clinical phenotype: temporal pattern of wheeze (EVW, SIW, MTW), history and clinical data, allergy diagnosis work-up Microbiological phenotype: viral status (PCR in nasal swab sample), bacteriological status (culture of induced sputum) Inflammatory phenotype: profile of cytokines, phenotype of immune cells in the blood and the sputum, cytokine response to TLR ligands by peripheral blood mononuclear cells will be assessed at the time of inclusion and at steady state 8 weeks later.
Children will be follow-up until the age of 7 (clinical data, control of asthma, lung function).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Episodic viral wheezers (EVW) | – | Other: Clinical, microbiological and inflammatory phenotypeEVW: Wheezing during discrete time periods (exacerbations), absence of symptoms between exacerbations Among which SIW: EVW with ≥ 2 exacerbations over the last 6 months Clinical, microbiological and inflammatory phenotype |
| Multiple trigger wheezers (MTW) | – | Other: Clinical, microbiological and inflammatory phenotypeMTW : wheezing during exacerbations but also symptoms between episodes. Clinical, microbiological and inflammatory phenotype |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preschool asthmatic children hospitalized for a severe exacerbation (requiring a course of systemic steroids), in a pediatric ward of one of the hospitals involved in the study, in the Hauts-de-France Region, France.
Key inclusion criteria (5 listed)
- Preschool children aged 1 to < 5 years
- Asthmatic / recurrent wheezers (≥ 3 discrete exacerbations since birth and/or symptoms between exacerbations, according to the definition from the French HAS and GINA guidelines)
- Hospitalized (less than 3 days ago) for a severe exacerbation (requiring a course of oral steroids)
- In a pediatric ward participating in the study (Hospital centers of Lille, Arras, Bethune, Douai, Lens, Roubaix, Tourcoing, Armentieres, Seclin)
- Parental consent
Key exclusion criteria (3 listed)
- History of chronic disease (other than asthma)
- History of preterm birth (inf 36 weeks of amenorrhea)
- Lack of understanding from the parents
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 |
|---|---|---|
| Clinical, microbiological and inflammatory phenotypeClinical phenotype: temporal pattern of wheeze (EVW, SIW, MTW), history and clinical data, allergy diagnosis work-up Microbiological phenotype: viral status (PCR in nasal swab sample), bacteriological status (culture of induced sputum) Inflammatory phenotype: profile of cytokines, phenotype of immune cells in the blood and the sputum, cytokine response to TLR ligands by peripheral blood mononuclear cells. | Other | Episodic viral wheezers (EVW), Multiple trigger wheezers (MTW) |
Primary outcome
Inflammatory profile at exacerbation
Time frame: At the time of the inclusion
concentration levels of IFNg, IL-5, IL-13, IL-33, TSLP in blood and induced sputum (all concentrations expressed in pg/ml, obtained with multiplex assays) between wheeze patterns: EVW (among which SIW) vs MTW
28 secondary outcomes
Inflammatory profile at steady state
Time frame: at baseline: consult at least 8 weeks after exacerbation
Change of inflammatory profile between exacerbation and steady state
Time frame: At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation)
Levels of cytokines in blood
Time frame: At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation)
Levels of cytokines in induced sputum
Time frame: At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation)
Levels of interferons in blood
Time frame: At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation)
Levels of interferons in induced sputum
Time frame: At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation)
Levels of chemokines in blood
Time frame: At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation)
Levels of chemokines in induced sputum
Time frame: At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation)
Expression patterns of mononuclear cells
Time frame: At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation)
Percentage of patients with tobacco exposure
Time frame: At the time of the inclusion
Percentage of patients with mould/moisture exposure
Time frame: At the time of the inclusion
Percentage of patients with pet ownership
Time frame: At the time of the inclusion
Percentage of patients living in urban area
Time frame: At the time of the inclusion
number of asthma exacerbations in the previous year
Time frame: At the time of the inclusion
Percentage of patients with associated atopic diseases
Time frame: At the time of the inclusion
Control of asthma
Time frame: At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation)
Features of the exacerbation: severity
Time frame: At the time of the inclusion
Features of the exacerbation: length
Time frame: At the time of the inclusion
Atopy
Time frame: At the time of the inclusion and at the age of 7
Blood leukocyte count
Time frame: At the time of the inclusion and at the age of 7
ImmunoCAP ISAC (Thermo Fisher Scientific)
Time frame: At the time of the inclusion and at the age of 7
Microbiological phenotype: viral status
Time frame: At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation)
Microbiological phenotype: bacteriological status
Time frame: At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation)
History at the age of 7
Time frame: At the age of 7
Control of asthma at the age of 7
Time frame: At the age of 7
Atopy at the age of 7
Time frame: At the age of 7
Lung function at the age of 7: forced expiratory volume in one second
Time frame: At the age of 7
Lung function at the age of 7 : forced vital capacity
Time frame: At the age of 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Antoine Deschildre, MD principal investigator
University Hospital, Lille
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by University Hospital, Lille.
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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Inflammatory profile at exacerbation (time frame: At the time of the inclusion). 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 16 Dec 2025.