AsthmaPEDIASTHMANCT05070663
A Study in Male and Female Adolescent Participants With Severe Uncontrolled Asthma Starting Treatment With Dupilumab Injection (Dupixent®)
An observational study of Asthma, run by Sanofi at 1 site in France.
Trial summary
Primary objective: Describe the characteristics of enrolled severe asthma patients Secondary objectives: Assess the control of asthma under dupilumab (Dupixent®) treatment until 1 year Assess the clinical objectives of the asthma care Assess comorbidities associated with Type 2 inflammation Assess safety during the… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Asthma
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- 4 Nov 2021to 3 Mar 2025
- How long will I take part?
- 52 Weeks
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Adolescents, for whom initiation of dupilumab (Dupixent®) for the severe uncontrolled asthma indication was decided by the investigator before the inclusion in the study.
Who may be able to join
- Adolescents, for whom initiation of dupilumab (Dupixent®) for the severe uncontrolled asthma indication was decided by the investigator before the inclusion in the study
- Adolescents ≥ 12 and < 18 years of age at the time of the initiation of Dupixent® treatment
Who cannot join
- Adult participants ≥ 18 years of age
- The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: National, Multicentre, Non-interventional, Prospective and Retrospective Study in Adolescent Patients With Severe Uncontrolled Asthma Starting Treatment With Dupilumab (Dupixent®)
Primary objective:
- Describe the characteristics of enrolled severe asthma patients
Secondary objectives:
- Assess the control of asthma under dupilumab (Dupixent®) treatment until 1 year
- Assess the clinical objectives of the asthma care
- Assess comorbidities associated with Type 2 inflammation
- Assess safety during the year of treatment
Read the detailed description
52 weeks
- Conditions
- Asthma
- 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 |
|---|---|---|
| Participants with severe asthma | Adolescents, for whom initiation of dupilumab (Dupixent®) for the severe uncontrolled asthma indication was decided by the investigator before the inclusion in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical history (including history of asthma)
Relevant medical history other than asthma according to the investigator (including documented comorbidities associated with type 2 inflammation). Asthma history includes patient age at the time of diagnosis and family history.
Measured: At the start of treatment with Dupixent® (day 1)
Previous treatments for asthma
Background asthma treatments (doses and international nonproprietary name (INN) of inhaled corticosteroids (ICS), long-acting beta-2 agonist (LABA) and oral corticosteroids (OCS), etc) including cumulative yearly dose of OCS. Use of oral corticosteroids due to exacerbation of asthma (dose, INN). Use of emergency treatments (short-acting beta-2 agonist (SABA)) (number of times per week).
Measured: At the start of treatment with Dupixent® (day 1)
Demographic characteristics
Age and gender.
Measured: At the start of treatment with Dupixent® (day 1)
Disease characteristics
Disease characteristics at the inclusion including severity (Global Initiative for Asthma (GINA) step), number of severe exacerbations during the past year, number of days in intensive care unit (ICU) for severe exacerbation since the diagnosis, forced expiratory volume per second (FEV1), Asthma Control Test (ACT) score.
Measured: At the start of treatment with Dupixent® (day 1)
Concomitant medication
Relevant concomitant medication other than medication for asthma according to the investigator.
Measured: At the start of treatment with Dupixent® (day 1)
Secondary outcomes (14)
Change from baseline to week 52 in asthma control test (ACT) score at each subsequent visit over the year of treatment
ACT score range: 5-25; higher score indicates better asthma control.
Measured: From baseline (day 1) to week 52
Change from baseline to week 52 in number of annualized exacerbations and description of exacerbation setting
An exacerbation is defined as deterioration of asthma requiring use of systemic corticosteroids for ≥3 days; or increase in oral corticosteroids (OCS) dose at ≥2 times the current dose for ≥3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.
Measured: From baseline (day 1) to week 52
Change from baseline to week 52 in Paediatric Asthma Quality of Life Questionnaire (PAQLQ) score
Questionnaire including 23 questions in 3 domains (symptoms, activity limitation, emotional function) and a 7-point scale (7 = not bothered at all; 1 = extremely bothered).
Measured: From baseline (day 1) to week 52
Change from baseline to week 52 in corticosteroid dose
Change in corticosteroid dose.
Measured: From baseline (day 1) to week 52
Change from baseline to week 52 in pre- bronchodilator forced expiratory volume per second (FEV1)
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Measured: From baseline (day 1) to week 52
Change from baseline to week 52 in number of food allergic reactions
Following food allergic reactions will be recorded: allergic symptoms and anaphylaxis in real life or during an oral food challenge.
Measured: From baseline (day 1) to week 52
Change from baseline to week 52 in in visual analogue scale (VAS) score for allergic rhinitis
VAS score range: 0 ('no symptoms') to 100 ('severe symptoms').
Measured: From baseline (day 1) to week 52
Change from baseline to week 52 in in Score for atopic dermatitis (SCORAD) score for atopic dermatitis
SCORAD is a clinical tool for assessing the severity (i.e., extent, intensity) of atopic dermatitis as objectively as possible with scores ranging from 0-100. The higher the score indicates more severe atopic dermatitis.
Measured: From baseline (day 1) to week 52
Change from baseline to week 52 in sinonasal symptoms of nasal polyposis of food allergies
Following sinonasal symptoms will be recorded: nasal congestion, loss in smell, posterior nasal discharge, anterior nasal discharge.
Measured: From baseline (day 1) to week 52
Responder rates at week 52 for ACT (according to the minimal important difference (MID))
A participant is defined as responder if he/she has a change from baseline of 3 points or more at week 52 on the ACT score. ACT score range: 5-25; higher score indicates better asthma control.
Measured: At week 52
Responder rates at week 52 for PAQLQ (according to the MID))
A participant is defined as responder if he/she has a change from baseline of 0.5 points or more at week 52 on the PAQLQ score. The PAQLQ(S) overall score is calculated by adding points of individual responses to all questions, with the higher scores indicating less impairment that is, a better quality of life. Questionnaire including 23 questions in 3 domains (symptoms, activity limitation, emotional function) and a 7-point scale (7 = not bothered at all; 1 = extremely bothered).
Measured: At week 52
Reasons for Dupixent® discontinuation
All reasons for treatment discontinuation.
Measured: Day 1 to week 52
Collection of adverse events
Number of adverse events.
Measured: Day 1 to week 52
Collection of serious adverse events
Number of serious adverse events.
Measured: Day 1 to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start4 Nov 2021
- Primary completion14 Mar 2024
- Study completion3 Mar 2025
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 AsthmaStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Other
- Enrolment
- 105 participants (actual)
- Target duration
- 52 Weeks
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070663
- Sponsor's protocol ID
- OBS17083
- Other IDs
- U1111-1256-9593
- Acronym
- PEDIASTHMA
- Status last verified
- Jun 2026
- First submitted
- 27 Sep 2021
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Publications
Wanin S, Taam RA, Chami LG, Marguet C, Just J, Da Silva C, Msihid J, Ledanois O, Gall R, Sacks HJ, Jacob-Nara JA, Daridon C, Deschildre A. Characteristics of Adolescents With Uncontrolled Severe Asthma Starting Dupilumab: The PEDIASTHMA Registry. Allergy. 2026 Jan;81(1):292-296. doi: 10.1111/all.70119. Epub 2025 Oct 29. No abstract available.
PubMed 41163372
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National, Multicentre, Non-interventional, Prospective and Retrospective Study in Adolescent Patients With Severe Uncontrolled Asthma Starting Treatment With Dupilumab (Dupixent®)
- ClinicalTrials.gov ID
- NCT05070663
- Acronym / sponsor ID
- PEDIASTHMA / OBS17083
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 7 Oct 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.
Primary objective:
- Describe the characteristics of enrolled severe asthma patients
Secondary objectives:
- Assess the control of asthma under dupilumab (Dupixent®) treatment until 1 year
- Assess the clinical objectives of the asthma care
- Assess comorbidities associated with Type 2 inflammation
- Assess safety during the year of treatment
Detailed description
52 weeks
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 52 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with severe asthma | – | –Adolescents, for whom initiation of dupilumab (Dupixent®) for the severe uncontrolled asthma indication was decided by the investigator before the inclusion in the study. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Adolescents, for whom initiation of dupilumab (Dupixent®) for the severe uncontrolled asthma indication was decided by the investigator before the inclusion in the study.
Key inclusion criteria (2 listed)
- Adolescents, for whom initiation of dupilumab (Dupixent®) for the severe uncontrolled asthma indication was decided by the investigator before the inclusion in the study
- Adolescents ≥ 12 and < 18 years of age at the time of the initiation of Dupixent® treatment
Key exclusion criteria (2 listed)
- Adult participants ≥ 18 years of age
- The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
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
Medical history (including history of asthma)
Time frame: At the start of treatment with Dupixent® (day 1)
Relevant medical history other than asthma according to the investigator (including documented comorbidities associated with type 2 inflammation). Asthma history includes patient age at the time of diagnosis and family history.
Previous treatments for asthma
Time frame: At the start of treatment with Dupixent® (day 1)
Background asthma treatments (doses and international nonproprietary name (INN) of inhaled corticosteroids (ICS), long-acting beta-2 agonist (LABA) and oral corticosteroids (OCS), etc) including cumulative yearly dose of OCS. Use of oral corticosteroids due to exacerbation of asthma (dose, INN). Use of emergency treatments (short-acting beta-2 agonist (SABA)) (number of times per week).
Demographic characteristics
Time frame: At the start of treatment with Dupixent® (day 1)
Age and gender.
Disease characteristics
Time frame: At the start of treatment with Dupixent® (day 1)
Disease characteristics at the inclusion including severity (Global Initiative for Asthma (GINA) step), number of severe exacerbations during the past year, number of days in intensive care unit (ICU) for severe exacerbation since the diagnosis, forced expiratory volume per second (FEV1), Asthma Control Test (ACT) score.
Concomitant medication
Time frame: At the start of treatment with Dupixent® (day 1)
Relevant concomitant medication other than medication for asthma according to the investigator.
14 secondary outcomes
Change from baseline to week 52 in asthma control test (ACT) score at each subsequent visit over the year of treatment
Time frame: From baseline (day 1) to week 52
Change from baseline to week 52 in number of annualized exacerbations and description of exacerbation setting
Time frame: From baseline (day 1) to week 52
Change from baseline to week 52 in Paediatric Asthma Quality of Life Questionnaire (PAQLQ) score
Time frame: From baseline (day 1) to week 52
Change from baseline to week 52 in corticosteroid dose
Time frame: From baseline (day 1) to week 52
Change from baseline to week 52 in pre- bronchodilator forced expiratory volume per second (FEV1)
Time frame: From baseline (day 1) to week 52
Change from baseline to week 52 in number of food allergic reactions
Time frame: From baseline (day 1) to week 52
Change from baseline to week 52 in in visual analogue scale (VAS) score for allergic rhinitis
Time frame: From baseline (day 1) to week 52
Change from baseline to week 52 in in Score for atopic dermatitis (SCORAD) score for atopic dermatitis
Time frame: From baseline (day 1) to week 52
Change from baseline to week 52 in sinonasal symptoms of nasal polyposis of food allergies
Time frame: From baseline (day 1) to week 52
Responder rates at week 52 for ACT (according to the minimal important difference (MID))
Time frame: At week 52
Responder rates at week 52 for PAQLQ (according to the MID))
Time frame: At week 52
Reasons for Dupixent® discontinuation
Time frame: Day 1 to week 52
Collection of adverse events
Time frame: Day 1 to week 52
Collection of serious adverse events
Time frame: Day 1 to week 52
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 5 Jun 2026.
- Results publication: PubMed 41163372Wanin S, Taam RA, Chami LG, Marguet C, Just J, Da Silva C, Msihid J, Ledanois O, Gall R, Sacks HJ, Jacob-Nara JA, Daridon C, Deschildre A. Characteristics of Adolescents With Uncontrolled Severe Asthma Starting Dupilumab: The PEDIASTHMA Registry. Allergy. 2026 Jan;81(1):292-296. doi: 10.1111/all.70119. Epub 2025 Oct 29. No abstract available.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
Clinical Sciences & Operations study director
Sanofi
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 Asthma, run by Sanofi 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: finished, as of the sponsor's last update on 5 Jun 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?
Medical history (including history of asthma) (time frame: At the start of treatment with Dupixent® (day 1)). The study lists 5 primary outcomes in all. 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 NCT05070663, 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 5 Jun 2026.