Severe AsthmaCOBRAPedNCT02114034
Cohort Analysis of Clinical and Biological Severe Childhood Asthma
An observational study of Severe Asthma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this prospective study is: to identify by cluster analysis the main phenotypes of severe asthma and factors involved in the severity, to determine the clinical and functional outcomes, to identify the factors associated with severe asthma from childhood to adulthood. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Severe Asthma
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 362 participants
- Where
- 1 siteFrance
- Study dates
- 12 Nov 2013to Nov 2032
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Primary Care Clinic
Who may be able to join
- Children with severe asthma:
- Child aged 3 to 12 years
- Asthmatic child who, despite treatment with a combination of inhaled corticosteroids (at least 800 mcg / day equivalent Beclomethasone) bronchodilators and long-acting or properly taken daily leukotriene or short acting nebulized bronchodilators (inhaler technique and compliance verified) presents one of the criteria following:
- Persistence of symptoms or chronic use of bronchodilators short duration of action at least three times a week for at least 3 months
- exacerbations in the previous year:
- at least one care unit admission or continued resuscitation
Show all 18Show fewer
- at least two hospitalizations for acute severe asthma requiring IV therapy
- at least 2 courses of oral corticosteroids for exacerbations
- post BD FEV <80% or UARS post BD> 150% predicted
- Signature of consent or the holder (s) of parental authority
- Particular case of patients treated with Xolair® : Patients currently receiving Xolair® but who met the severity criteria of asthma, as described above, before the start of treatment with Xolair® are includable.
- Children with non-severe asthma:
- Child aged 3 to 12 years
- Controlled without treatment or with low doses of inhaled corticosteroids (<500 mg / day beclometasone equivalent) asthma
- Child with normal EFR (Child over 4 years)
- Child who did not have more severe exacerbation (assessed taking oral corticosteroids) in the previous year
- Child not admitted in the previous year for asthma.
- Signature of consent or the holder (s) of parental authority
Who cannot join
- Child with bronchopulmonary dysplasia
- Child with severe sequelae of viral infections
- Refusal of the child or parents Data collection for research and follow up of patients : tests carried out in the 3 months prior to inclusion are used
- Blood sample for DNA extraction and the biobank: for young children, sampling at least 4 to 5 ml on dry tubes for serum and 6 ml at least for DNA. These samples should be stored at room temperature, transported within 48 hours to biological resources (CRB) Necker E,fa,ts Malades.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Pneumologie et allergologie pédiatrique, Hôpital Necker-Enfants Malades
Paris, 75015
About this study
The purpose of this prospective study is:
- to identify by cluster analysis the main phenotypes of severe asthma and factors involved in the severity,
- to determine the clinical and functional outcomes,
- to identify the factors associated with severe asthma from childhood to adulthood.
Read the detailed description
Severe asthma involves about 5 % of asthmatic children and is associated with a high impact on hospitalizations, absenteeism and quality of life.
Although our knowledge has progressed in a substantial way during the last ten years, a number of unresolved questions persist in particular as regard to the contributing factors and outcomes from early childhood to adulthood.
After parental agreement the following elements will be collected at inclusion: clinical environmental data, pulmonary function, allergy test data (skin prick tests and specific IgE), blood and serum samples for biobank (DNA / SERUM). In a restricted number of children a more extensive work up will be performed which may include flexible bronchoscopy, bronchial brushing and bronchoalveolar lavage.
The follow-up will be performed every 6 months within the framework of the usual care including collection of clinical data and pulmonary function tests. The allergic status will be done again at 6-7 years, 12 years and 18 years.
In the group of children having non-severe asthma, the follow-up will be annual with collection of clinical data and pulmonary function tests.
- Conditions
- Severe Asthma
- Keywords
- Severe asthma,, child,, outcome,
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-severe asthma | * Children Controlled without treatment or with low doses of inhaled corticosteroids (<500 mg / day beclometasone equivalent) asthma * and Children with normal EFR * and Children who did not have more severe exacerbation (assessed taking oral corticosteroids) in the previous year * and Children not admitted in the previous year for asthma | |
| Severe asthma | Asthmatic child who, despite treatment with a combination of inhaled corticosteroids (at least 800 mcg / day equivalent Beclomethasone) bronchodilators and long-acting or properly taken daily leukotriene (inhaler technique and compliance verified) presents one of the 3 criteria following: * Persistence of symptoms or chronic use of bronchodilators short duration of action at least three times a week for at least 3 months * exacerbations in the previous year: * at least one care unit admission or continued resuscitation * at least two hospitalizations for acute severe asthma requiring IV therapy * at least 2 courses of oral corticosteroids for exacerbations * post BD FEV <80% or UARS post BD> 150% predicted |
What is being measured
The primary outcome is the main question the study is designed to answer.
The identification of risk factors for severe asthma
A prospective follow-up of a cohort of severe pediatric asthma. To improve the identification of risk factors for severe asthma, a group of children with non-severe asthma will also be included
Measured: 18 years
Secondary outcomes (3)
In the medium and longer term assessment
- Identify the functional and clinical outcome in a longitudinal follow-up to a link with asthma in adults.
- Identify the factors involved appearing during growth or adulthood (pediatric factors associated with severe asthma profile adult).
Measured: 4 years
A short-term assessment
- Identify the main phenotypes of severe asthma by the cluster analysis
- Identify the factors involved in severity during childhood
Measured: 4 years
Establish a collection of biological samples (serum bank, DNA Bank, tissue Bank) to search for biomarkers of severity and genetic risk factors for the development of asthma in children.
Measured: 18 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study start12 Nov 2013
- Primary completionNov 2032 (estimated)
- Study completionNov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 362 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, MD, PhD, Principal investigator, Assistance Publique-Hôpitaux Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114034
- Sponsor's protocol ID
- NI12004
- Other IDs
- N° ID RCB: 2012-A00539-34
- Acronym
- COBRAPed
- Status last verified
- Sep 2025
- First submitted
- 22 Aug 2013
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lezmi G, Lejeune S, Pin I, Blanchon S, Bouazza N, Jolaine V, Marguet C, Houdoin V, Berger P, Fayon M, Dubus JC, Reix P, Pellan M, Brouard J, Chiron R, Giovannini-Chami L, Deschildre A, de Blic J; COBRAPed Study Group. Factors Associated with Asthma Severity in Children: Data from the French COBRAPed Cohort. J Allergy Clin Immunol Pract. 2021 May;9(5):1969-1979. doi: 10.1016/j.jaip.2020.12.027. Epub 2020 Dec 24.
PubMed 33359443
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Analysis of Clinical and Biological Severe Childhood Asthma
- ClinicalTrials.gov ID
- NCT02114034
- Acronym / sponsor ID
- COBRAPed / NI12004
- Conditions
- Severe Asthma
- Keywords
- Severe asthma,, child,, outcome,
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 12 Nov 2013 (actual)
- Primary completion
- Nov 2032 (estimated)
- Study completion
- Nov 2032 (estimated)
- First posted
- 15 Apr 2014 (estimated)
- 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 purpose of this prospective study is:
- to identify by cluster analysis the main phenotypes of severe asthma and factors involved in the severity,
- to determine the clinical and functional outcomes,
- to identify the factors associated with severe asthma from childhood to adulthood.
Detailed description
Severe asthma involves about 5 % of asthmatic children and is associated with a high impact on hospitalizations, absenteeism and quality of life.
Although our knowledge has progressed in a substantial way during the last ten years, a number of unresolved questions persist in particular as regard to the contributing factors and outcomes from early childhood to adulthood.
After parental agreement the following elements will be collected at inclusion: clinical environmental data, pulmonary function, allergy test data (skin prick tests and specific IgE), blood and serum samples for biobank (DNA / SERUM). In a restricted number of children a more extensive work up will be performed which may include flexible bronchoscopy, bronchial brushing and bronchoalveolar lavage.
The follow-up will be performed every 6 months within the framework of the usual care including collection of clinical data and pulmonary function tests. The allergic status will be done again at 6-7 years, 12 years and 18 years.
In the group of children having non-severe asthma, the follow-up will be annual with collection of clinical data and pulmonary function tests.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-severe asthma | – | –* Children Controlled without treatment or with low doses of inhaled corticosteroids (<500 mg / day beclometasone equivalent) asthma * and Children with normal EFR * and Children who did not have more severe exacerbation (assessed taking oral corticosteroids) in the previous year * and Children not admitted in the previous year for asthma |
| Severe asthma | – | –Asthmatic child who, despite treatment with a combination of inhaled corticosteroids (at least 800 mcg / day equivalent Beclomethasone) bronchodilators and long-acting or properly taken daily leukotriene (inhaler technique and compliance verified) presents one of the 3 criteria following: * Persistence of symptoms or chronic use of bronchodilators short duration of action at least three times a week for at least 3 months * exacerbations in the previous year: * at least one care unit admission or continued resuscitation * at least two hospitalizations for acute severe asthma requiring IV therapy * at least 2 courses of oral corticosteroids for exacerbations * post BD FEV <80% or UARS post BD> 150% predicted |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Primary Care Clinic
Key inclusion criteria (18 listed)
- Child aged 3 to 12 years
- Asthmatic child who, despite treatment with a combination of inhaled corticosteroids (at least 800 mcg / day equivalent Beclomethasone) bronchodilators and long-acting or properly taken daily leukotriene or short acting nebulized bronchodilators (inhaler technique and compliance verified) presents one of the criteria following:
- Persistence of symptoms or chronic use of bronchodilators short duration of action at least three times a week for at least 3 months
- exacerbations in the previous year:
- post BD FEV <80% or UARS post BD> 150% predicted
Key exclusion criteria (4 listed)
- Child with bronchopulmonary dysplasia
- Child with severe sequelae of viral infections
- Refusal of the child or parents Data collection for research and follow up of patients : tests carried out in the 3 months prior to inclusion are used
- Blood sample for DNA extraction and the biobank: for young children, sampling at least 4 to 5 ml on dry tubes for serum and 6 ml at least for DNA. These samples should be stored at room temperature, transported within 48 hours to biological resources (CRB) Necker E,fa,ts Malades.
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
The identification of risk factors for severe asthma
Time frame: 18 years
A prospective follow-up of a cohort of severe pediatric asthma. To improve the identification of risk factors for severe asthma, a group of children with non-severe asthma will also be included
3 secondary outcomes
In the medium and longer term assessment
Time frame: 4 years
A short-term assessment
Time frame: 4 years
Establish a collection of biological samples (serum bank, DNA Bank, tissue Bank) to search for biomarkers of severity and genetic risk factors for the development of asthma in children.
Time frame: 18 years
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 15 Sep 2025.
- Results publication: PubMed 33359443Lezmi G, Lejeune S, Pin I, Blanchon S, Bouazza N, Jolaine V, Marguet C, Houdoin V, Berger P, Fayon M, Dubus JC, Reix P, Pellan M, Brouard J, Chiron R, Giovannini-Chami L, Deschildre A, de Blic J; COBRAPed Study Group. Factors Associated with Asthma Severity in Children: Data from the French COBRAPed Cohort. J Allergy Clin Immunol Pract. 2021 May;9(5):1969-1979. doi: 10.1016/j.jaip.2020.12.027. Epub 2020 Dec 24.
- 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, MD, PhD principal investigator
Assistance Publique-Hôpitaux 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 18 inclusion and 4 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 15 Sep 2025. 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?
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?
The identification of risk factors for severe asthma (time frame: 18 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02114034, which also lists 1 linked publication.
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 15 Sep 2025.