Severe AsthmaSAMP 2NCT05762627
Severe Eosinophilic Asthma Phenotypes During Childhood Have Various Origins
An observational study of Severe Asthma and Asthma in Children, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Study of the clinical evolution at 10 years of children from the SAMP cohort (severe asthma, eosinophilic or not, allergic or not) in order to understand the different possible evolutions of these phenotypes at different ages. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Severe Asthma, Asthma in Children
- How many people
- 360 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2023to Mar 2027
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients from SAMP cohort
Who may be able to join
- absence of opposition from the legal representative of the patient and if possible from the patient himself.
- patient with moderate to severe asthma at preschool or school age, previously included in SAMP Cohort
Who cannot join
- Patient included in another clinical study.
- Lack of coverage by social security.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Trajectories of Severe Eosinophilic Asthma During Childhood: Experience of the SAMP (Severe Asthma Molecular Phenotype) Cohort
Study of the clinical evolution at 10 years of children from the SAMP cohort (severe asthma, eosinophilic or not, allergic or not) in order to understand the different possible evolutions of these phenotypes at different ages.
Read the detailed description
Multiple sensitizations but also blood eosinophilia are associated with the persistence of exacerbations during childhood. The pivotal role of eosinophilia in the pathophysiology of allergic asthma and more generally of severe asthma in the pediatric population has made it an important research topic for many years. The indirect demonstration of bronchial inflammation by analyzing blood eosinophilia is common practice, especially when monitoring the effectiveness of biotherapies. However, blood eosinophilia is not always clearly related to bronchial eosinophilia.
On the other hand, several teams have recently sought to highlight the recurrence of allergen sensitization profiles associated with severe asthma, in order to identify predictive factors of clinical evolution.
Finally, recent studies have shown that the nasal microbiota plays an important role in the onset, development and severity of asthma.
Our study will allow us to study the clinical evolution at 10 years of the children from the SAMP cohort (severe asthma, eosinophilic or not, allergic or not) in order to understand the different possible evolutions of these phenotypes at different ages. These phenotypic trajectories have an important therapeutic implication, leading to the prescription of personalized treatments, in particular biologics (monoclonal antibodies).
Primary objective To evaluate, in children with moderate to severe asthma, the control of asthma according to the therapeutic load, atopic pathologies during childhood and initial serum levels of blood eosinophils and biomarkers of eosinophil activation Secondary objective Evaluate the evolution of asthma phenotypes according to the associated atopic pathologies (allergic rhinitis, atopic dermatitis and food allergy), according to the number of atopic comorbidities and their severity.
Study of the microbiota in children followed for moderate to severe asthma.
Practical procedure The investigator record the new tests prescribed as part of the routine care of these patients (respiratory function tests, blood tests) and ask them to complete a questionnaire (no travel required specifically for the study). In the event of a blood test prescribed and carried out in the department, the investigator will take an additional 2 ml, and perform a nasal and skin swab.
- Conditions
- Severe Asthma, Asthma in Children
- Keywords
- Childhood severe asthma, Eosinophilic asthma, Allergic asthma, Asthma trajectories, Type 2 inflammation
- Medical subject headings
- Asthma, Pulmonary Eosinophilia
What is being measured
The primary outcome is the main question the study is designed to answer.
asthma control 1
Asthma control according to GINA (Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2020. www.ginasthma.org.)
Measured: through study completion, 4 years
asthma control 2
Score of the Asthma Control Test (for children > 11 years old) and of the Asthma Control Test reserved for asthmatic children from 4 to 11 years old (ACT™, © 2002, by QualityMetric Incorporated Asthma France / French Control Test™ is a trademark of QualityMetric Incorporated. www.asthmacontroltest.com)
Measured: through study completion, 4 years
Secondary outcomes (6)
asthma severity 1
Asthma severity according to GINA (Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2022. www.ginasthma.org.)
Measured: through study completion, 4 years
asthma severity 2
Respiratory function tests (spirometry and plethysmography)
Measured: through study completion, 4 years
atopic comorbidities 1
Rhinitis control score: ARIA score (Allergic Rhinitis and its Impact on Asthma) endorsed by the WHO (Bousquet J, van Cauwenberge P, Khaltaev N, and the WHO panel members: Allergic Rhinitis and Its Impact on Asthma. ARIA. In collaboration with the World Health Organization. J Allergy Clin Immunol 2001; 108: S1-S315)
Measured: through study completion, 4 years
atopic comorbidities 2
Eczema control score: SCORAD score (Scoring atopic dermatitis) (Dermatology 1993; n°186 p23-p31. European Task Force of Atopic Dermatitis)
Measured: through study completion, 4 years
atopic comorbidities 3
Food allergy
Measured: through study completion, 4 years
nasal and skin microbiota
nasal and skin swabs for research of colonization with staphylococcus aureus
Measured: 1 day at inclusion of patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study startMar 2023 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2027 (estimated)
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
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mélisande Bourgoin-Heck, MD, MSc, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762627
- Sponsor's protocol ID
- APHP220980
- Acronym
- SAMP 2
- Status last verified
- Feb 2023
- First submitted
- 7 Dec 2022
- Last updated
- 9 Mar 2023
- 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 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trajectories of Severe Eosinophilic Asthma During Childhood: Experience of the SAMP (Severe Asthma Molecular Phenotype) Cohort
- ClinicalTrials.gov ID
- NCT05762627
- Acronym / sponsor ID
- SAMP 2 / APHP220980
- Conditions
- Severe Asthma, Asthma in Children
- Keywords
- Childhood severe asthma, Eosinophilic asthma, Allergic asthma, Asthma trajectories, Type 2 inflammation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 9 Mar 2023 (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.
Study of the clinical evolution at 10 years of children from the SAMP cohort (severe asthma, eosinophilic or not, allergic or not) in order to understand the different possible evolutions of these phenotypes at different ages.
Detailed description
Multiple sensitizations but also blood eosinophilia are associated with the persistence of exacerbations during childhood. The pivotal role of eosinophilia in the pathophysiology of allergic asthma and more generally of severe asthma in the pediatric population has made it an important research topic for many years. The indirect demonstration of bronchial inflammation by analyzing blood eosinophilia is common practice, especially when monitoring the effectiveness of biotherapies. However, blood eosinophilia is not always clearly related to bronchial eosinophilia.
On the other hand, several teams have recently sought to highlight the recurrence of allergen sensitization profiles associated with severe asthma, in order to identify predictive factors of clinical evolution.
Finally, recent studies have shown that the nasal microbiota plays an important role in the onset, development and severity of asthma.
Our study will allow us to study the clinical evolution at 10 years of the children from the SAMP cohort (severe asthma, eosinophilic or not, allergic or not) in order to understand the different possible evolutions of these phenotypes at different ages. These phenotypic trajectories have an important therapeutic implication, leading to the prescription of personalized treatments, in particular biologics (monoclonal antibodies).
Primary objective To evaluate, in children with moderate to severe asthma, the control of asthma according to the therapeutic load, atopic pathologies during childhood and initial serum levels of blood eosinophils and biomarkers of eosinophil activation Secondary objective Evaluate the evolution of asthma phenotypes according to the associated atopic pathologies (allergic rhinitis, atopic dermatitis and food allergy), according to the number of atopic comorbidities and their severity.
Study of the microbiota in children followed for moderate to severe asthma.
Practical procedure The investigator record the new tests prescribed as part of the routine care of these patients (respiratory function tests, blood tests) and ask them to complete a questionnaire (no travel required specifically for the study). In the event of a blood test prescribed and carried out in the department, the investigator will take an additional 2 ml, and perform a nasal and skin swab.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from SAMP cohort
Key inclusion criteria (2 listed)
- absence of opposition from the legal representative of the patient and if possible from the patient himself.
- patient with moderate to severe asthma at preschool or school age, previously included in SAMP Cohort
Key exclusion criteria (2 listed)
- Patient included in another clinical study.
- Lack of coverage by social security.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
asthma control 1
Time frame: through study completion, 4 years
Asthma control according to GINA (Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2020. www.ginasthma.org.)
asthma control 2
Time frame: through study completion, 4 years
Score of the Asthma Control Test (for children > 11 years old) and of the Asthma Control Test reserved for asthmatic children from 4 to 11 years old (ACT™, © 2002, by QualityMetric Incorporated Asthma France / French Control Test™ is a trademark of QualityMetric Incorporated. www.asthmacontroltest.com)
6 secondary outcomes
asthma severity 1
Time frame: through study completion, 4 years
asthma severity 2
Time frame: through study completion, 4 years
atopic comorbidities 1
Time frame: through study completion, 4 years
atopic comorbidities 2
Time frame: through study completion, 4 years
atopic comorbidities 3
Time frame: through study completion, 4 years
nasal and skin microbiota
Time frame: 1 day at inclusion of patient
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 9 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
Mélisande Bourgoin-Heck, MD, MSc 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 and Asthma in Children, 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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 9 Mar 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?
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?
Contact Mélisande Bourgoin-Heck, MD, MSc (+33 (0)1-71-73-87-46, Melisande.bourgoin-heck@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
asthma control 1 (time frame: through study completion, 4 years). The study lists 2 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 9 Mar 2023.