Severe AsthmaS2AEANCT05032209
Follow-up of Children With Severe Asthma at Adult Age
An observational study of Severe Asthma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Most of clinical cohorts focused on the course of asthma over time and on the different phenotypes of asthma have investigated children and adults separately. The passage from childhood to adulthood is scarcely explored. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Asthma
- What is being tested?
- follow-up of children with severe asthma in adulthood
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jul 2021to 12 Jul 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinical cohort of adults patients with severe asthma in childhood
Who may be able to join
- to be aged at least 18 years old in 2021
- Have had an evaluation for severe asthma during childhood at Trousseau Hospital or Robert Debré Hospital
- Affiliation to an health insurance coverage. Non-inclusion criteria
Who cannot join
- Patient without severe asthma at the time of the assessment in childhood
- Patient with an associated respiratory disease other than asthma (bronchopulmonary dysplasia, cystic fibrosis, primary ciliary dyskinesia) whose diagnosis has been invalidated or confirmed during the initial assessment
- Patient opposition
Trial locations and contacts
1 site in 1 country.
About this study
Most of clinical cohorts focused on the course of asthma over time and on the different phenotypes of asthma have investigated children and adults separately. The passage from childhood to adulthood is scarcely explored.
In this context, we decided to explore the course of asthma severity from teenage to adulthood in children with severe asthma. The secondary objectives are to assess the quality of life and socioeconomic status in adulthood.
This study will be both retrospective (data collected during childhood) and prospective (data collected during adulthood), multicentric and observational
Read the detailed description
Asthma is one of the most frequent pediatric chronic disease; between 30% and 50% of preschoolers have one to more episodes of wheezing, but less than half of them will have asthma persisting during childhood .Over the past decades, several longitudinal studies have described the different trajectories of asthma depending on the initial phenotype. The results of the MAS study (Melbourne Asthma Study), including 330 patients followed from the age of 7 to the age of 35 and then 50 years, showed that the most symptomatic asthma at school age was most at risk of persisting into adulthood. Risk factors for persisting symptomatic asthma were female gender, history of atopic dermatitis, changes in respiratory function in childhood, parental history of asthma, early onset of asthma, and frequency exacerbations in childhood. Thus, severe childhood asthma is more likely to persist in adulthood while mild asthma is more likely to go into remission. Long-term remission is still possible; in the MAS cohort, 15% of patients with severe childhood asthma were in complete remission by the age of 50 years.Severe asthma is poorly represented in studies from the general population or neonatal cohorts, as it remains rare in children. However, there are several clinical studies supporting at least a partial improvement in symptoms in adulthood. Thus, in a Dutch cohort of asthmatic children followed in a tertiary center and re-assessed in their 2nd and 3rd decades, asthma symptoms returned to at least partial remission in 52% of patients. However, only a minority of them (42%) had complete remission of their symptoms and normal respiratory function.Most of the clinical cohort studies examining the prognosis of asthma during time explored separately children and adults. Some biomarkers are lacking in children and the passage from childhood to adulthood is not explored. The usual phenotypic description takes into account the presence or absence of atopy, the frequency of symptoms, the factors triggering exacerbations, the severity of the disease, some biomarkers of inflammation and the level of control under treatment. The difficulty of accessing biomarkers from the deep lung in children and the binary analysis of some variables such as atopy make the description and the analysis of risk factors for persistence of asthma in adulthood difficult.
In addition, the prognosis of asthma is not only influenced by biological and environmental factors, but also by social factors throughout life. Thus, a low socioeconomic level is a recognized risk factor for severe acute asthma and poor asthma control.Finally, beyond the medium and long term prognosis, severe asthma is associated with an impaired quality of life, in children as well as in adults.In this context, the main objective of this study is to determine the course of asthma from childhood to young adulthood in a population of children with severe persistent asthma. The secondary objectives are to determine the phenotypic evolution of asthma (in particular atopic co-morbidities); to Compare the severity of asthma in adulthood according to the initial phenotypes of asthma in childhood, integrating clinical, functional, radiological, and biological parameters (including biomarkers from the deep lung);to describe the quality of life of these patients in adulthood and their socio-economic status.The primary endpoint is the classification of the severity and control of asthma in adulthood according to the GINA criteria.The secondary endpoints will be :
- When assessing severe asthma in childhood: Demographic data: age, sex, term of birth, socio-economic level of parents according to INSEE (high, intermediate or low), geographic origin of parents, body mass index.
Environmental data: exposure to irritants and potential allergens. Anamnestic data: history of familial asthma, time to disease progression, history of pneumonia, bronchopulmonary dysplasia.
Associated co-morbidities: existence of allergic rhinitis assessed by the SFAR diagnostic score and the ARIA severity score, atopic dermatitis, food allergy, clinical gastroesophageal reflux disease or proven by pHmetry.
Results of additional assessments: bronchial endoscopy, functional respiratory data, blood eosinophilia, existence of allergen sensitization
During Adulthood :
Demographic data: age at time of collection, BMI. Social data: level of education, socio-professional category according to INSEE, disability, health insurance, number of days of school or professional absenteeism for asthma out of the 12 last months.
Environmental data: exposure to irritants and potential allergens. Associated co-morbidities: allergic rhinitis assessed by the SFAR diagnostic score and the ARIA severity score, atopic dermatitis, food allergy, gastroesophageal reflux disease Evaluation of the quality of life by the mini-AQLQ score. Results of additional examinations carried out in the year of the assessment: Respiratory functional data.
During Adulthood :
Demographic data: age at time of collection, BMI. Social data: level of education, socio-professional category according to INSEE, disability, health insurance, number of days of school or professional absenteeism for asthma out of the 12 last months.
Environmental data: exposure to irritants and potential allergens. Associated co-morbidities: allergic rhinitis assessed by the SFAR diagnostic score and the ARIA severity score, atopic dermatitis, food allergy, gastroesophageal reflux disease Evaluation of the quality of life by the mini-AQLQ score.
Results of additional examinations carried out in the year of the assessment: Respiratory functional data.Design of the study : Multicentric, observational, both retrospective and prospective study. Inclusion and non-inclusion criteria :
Inclusion criteria
- to be aged at least 18 years old in 2021
- Have had an evaluation for severe asthma during childhood at Trousseau Hospital or Robert Debré Hospital
- Affiliation to an health insurance coverage. Non-inclusion criteria
- Patient without severe asthma at the time of the assessment in childhood
- Patient with an associated respiratory disease other than asthma (bronchopulmonary dysplasia, cystic fibrosis, primary ciliary dyskinesia) whose diagnosis has been invalidated or confirmed during the initial assessment
- Patient opposition
- Conditions
- Severe Asthma
- Being tested
- follow-up of children with severe asthma in adulthood
- Keywords
- childhood, adulthood
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follow-up of children with severe asthma in adulthoodOther
follow-up of children with severe asthma in adulthood
What is being measured
The primary outcome is the main question the study is designed to answer.
severity and control of asthma in adulthood according to the GINA criteria
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start12 Jul 2021
- Primary completion12 Jul 2022
- Study completion12 Jul 2022
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Flore AMAT, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032209
- Sponsor's protocol ID
- APHP210852
- Other IDs
- IDRCB: 2021-A00825-36
- Acronym
- S2AEA
- Status last verified
- Nov 2026
- First submitted
- 27 Aug 2021
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Children With Severe Asthma at Adult Age
- ClinicalTrials.gov ID
- NCT05032209
- Acronym / sponsor ID
- S2AEA / APHP210852
- Conditions
- Severe Asthma
- Keywords
- childhood, adulthood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 2 Sep 2021 (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.
Most of clinical cohorts focused on the course of asthma over time and on the different phenotypes of asthma have investigated children and adults separately. The passage from childhood to adulthood is scarcely explored.
In this context, we decided to explore the course of asthma severity from teenage to adulthood in children with severe asthma. The secondary objectives are to assess the quality of life and socioeconomic status in adulthood.
This study will be both retrospective (data collected during childhood) and prospective (data collected during adulthood), multicentric and observational
Detailed description
Asthma is one of the most frequent pediatric chronic disease; between 30% and 50% of preschoolers have one to more episodes of wheezing, but less than half of them will have asthma persisting during childhood .Over the past decades, several longitudinal studies have described the different trajectories of asthma depending on the initial phenotype. The results of the MAS study (Melbourne Asthma Study), including 330 patients followed from the age of 7 to the age of 35 and then 50 years, showed that the most symptomatic asthma at school age was most at risk of persisting into adulthood. Risk factors for persisting symptomatic asthma were female gender, history of atopic dermatitis, changes in respiratory function in childhood, parental history of asthma, early onset of asthma, and frequency exacerbations in childhood. Thus, severe childhood asthma is more likely to persist in adulthood while mild asthma is more likely to go into remission. Long-term remission is still possible; in the MAS cohort, 15% of patients with severe childhood asthma were in complete remission by the age of 50 years.Severe asthma is poorly represented in studies from the general population or neonatal cohorts, as it remains rare in children. However, there are several clinical studies supporting at least a partial improvement in symptoms in adulthood. Thus, in a Dutch cohort of asthmatic children followed in a tertiary center and re-assessed in their 2nd and 3rd decades, asthma symptoms returned to at least partial remission in 52% of patients. However, only a minority of them (42%) had complete remission of their symptoms and normal respiratory function.Most of the clinical cohort studies examining the prognosis of asthma during time explored separately children and adults. Some biomarkers are lacking in children and the passage from childhood to adulthood is not explored. The usual phenotypic description takes into account the presence or absence of atopy, the frequency of symptoms, the factors triggering exacerbations, the severity of the disease, some biomarkers of inflammation and the level of control under treatment. The difficulty of accessing biomarkers from the deep lung in children and the binary analysis of some variables such as atopy make the description and the analysis of risk factors for persistence of asthma in adulthood difficult.
In addition, the prognosis of asthma is not only influenced by biological and environmental factors, but also by social factors throughout life. Thus, a low socioeconomic level is a recognized risk factor for severe acute asthma and poor asthma control.Finally, beyond the medium and long term prognosis, severe asthma is associated with an impaired quality of life, in children as well as in adults.In this context, the main objective of this study is to determine the course of asthma from childhood to young adulthood in a population of children with severe persistent asthma. The secondary objectives are to determine the phenotypic evolution of asthma (in particular atopic co-morbidities); to Compare the severity of asthma in adulthood according to the initial phenotypes of asthma in childhood, integrating clinical, functional, radiological, and biological parameters (including biomarkers from the deep lung);to describe the quality of life of these patients in adulthood and their socio-economic status.The primary endpoint is the classification of the severity and control of asthma in adulthood according to the GINA criteria.The secondary endpoints will be :
- When assessing severe asthma in childhood: Demographic data: age, sex, term of birth, socio-economic level of parents according to INSEE (high, intermediate or low), geographic origin of parents, body mass index.
Environmental data: exposure to irritants and potential allergens. Anamnestic data: history of familial asthma, time to disease progression, history of pneumonia, bronchopulmonary dysplasia.
Associated co-morbidities: existence of allergic rhinitis assessed by the SFAR diagnostic score and the ARIA severity score, atopic dermatitis, food allergy, clinical gastroesophageal reflux disease or proven by pHmetry.
Results of additional assessments: bronchial endoscopy, functional respiratory data, blood eosinophilia, existence of allergen sensitization
During Adulthood :
Demographic data: age at time of collection, BMI. Social data: level of education, socio-professional category according to INSEE, disability, health insurance, number of days of school or professional absenteeism for asthma out of the 12 last months.
Environmental data: exposure to irritants and potential allergens. Associated co-morbidities: allergic rhinitis assessed by the SFAR diagnostic score and the ARIA severity score, atopic dermatitis, food allergy, gastroesophageal reflux disease Evaluation of the quality of life by the mini-AQLQ score. Results of additional examinations carried out in the year of the assessment: Respiratory functional data.
During Adulthood :
Demographic data: age at time of collection, BMI. Social data: level of education, socio-professional category according to INSEE, disability, health insurance, number of days of school or professional absenteeism for asthma out of the 12 last months.
Environmental data: exposure to irritants and potential allergens. Associated co-morbidities: allergic rhinitis assessed by the SFAR diagnostic score and the ARIA severity score, atopic dermatitis, food allergy, gastroesophageal reflux disease Evaluation of the quality of life by the mini-AQLQ score.
Results of additional examinations carried out in the year of the assessment: Respiratory functional data.Design of the study : Multicentric, observational, both retrospective and prospective study. Inclusion and non-inclusion criteria :
Inclusion criteria
- to be aged at least 18 years old in 2021
- Have had an evaluation for severe asthma during childhood at Trousseau Hospital or Robert Debré Hospital
- Affiliation to an health insurance coverage. Non-inclusion criteria
- Patient without severe asthma at the time of the assessment in childhood
- Patient with an associated respiratory disease other than asthma (bronchopulmonary dysplasia, cystic fibrosis, primary ciliary dyskinesia) whose diagnosis has been invalidated or confirmed during the initial assessment
- Patient opposition
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical cohort of adults patients with severe asthma in childhood
Key inclusion criteria (3 listed)
- to be aged at least 18 years old in 2021
- Have had an evaluation for severe asthma during childhood at Trousseau Hospital or Robert Debré Hospital
- Affiliation to an health insurance coverage. Non-inclusion criteria
Key exclusion criteria (3 listed)
- Patient without severe asthma at the time of the assessment in childhood
- Patient with an associated respiratory disease other than asthma (bronchopulmonary dysplasia, cystic fibrosis, primary ciliary dyskinesia) whose diagnosis has been invalidated or confirmed during the initial assessment
- Patient opposition
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 |
|---|---|---|
| follow-up of children with severe asthma in adulthoodfollow-up of children with severe asthma in adulthood | Other | – |
Primary outcome
severity and control of asthma in adulthood according to the GINA criteria
Time frame: 12 months
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 Nov 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Severe Asthma
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
RecruitingPhase 2
A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
Asthma
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig ( PF-07275315) in People With Severe Asthma
Asthma
RecruitingPhase 3
Phase 3b Study in Patients With Severe Asthma Treated With Tezepelumab
Severe Asthma
Active, not recruitingPhase 3
A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
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.
Flore AMAT, MD 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?
An observational study of 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?
The sponsor lists 3 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: finished, as of the sponsor's last update on 6 Nov 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?
severity and control of asthma in adulthood according to the GINA criteria (time frame: 12 months). 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 Nov 2026.