Asthma in ChildrenCASAMNCT05139381
Study for Children & Adolescent With Severe Asthma With an Eosinophilic Phenotype Treated With Mepolizumab
An observational study of Asthma in Children, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
Open label, observational cohort study conducted to collect demographics, clinical characteristics and outcome observational data from children (6-17 years) with a clinical diagnosis of severe asthma in 2 countries (Spain and United Kingdom), in public institutions. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Mepolizumab
- How many people
- 148 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Mar 2022to 12 Mar 2026
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: 100 paediatric patients (50 per country) using mepolizumab at severe asthma centres in the United Kingdom and Spain over 24-36 months.
Who may be able to join
- Patient who provides his/her written informed Consent to participate prior to commencing any study related activities.
- Children \& Adolescent aged 6-17 years at mepolizumab initiation
- Patient with a current clinical diagnosis of severe asthma (as per GINA / ATS / ERS / BTS criteria) and eosinophilic phenotype (as per mepolizumab licence) at mepolizumab initiation
- Patient currently under treatment or who initiates treatment with mepolizumab at the inclusion visit based on national asthma guidelines.
- Patient with relevant paper or electronic-based medical records available for 12-months prior to enrolment date/ index date (date of first mepolizumab injection) for clinically significant asthma exacerbation.
Who cannot join
- A participant will not be eligible for inclusion in this study if any of the following criteria apply: 3. Patient who does not meet the inclusion criteria. 4. Patient who has participated in an asthma monoclonal antibodies drug interventional clinical trial in the previous 12-months to mepolizumab initiation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Observational Study for Children & Adolescent With Severe Asthma With an Eosinophilic Phenotype Treated With Mepolizumab
Open label, observational cohort study conducted to collect demographics, clinical characteristics and outcome observational data from children (6-17 years) with a clinical diagnosis of severe asthma in 2 countries (Spain and United Kingdom), in public institutions.
All eligible participants who have a physician decision to initiate mepolizumab treatment and are consented for the study will be observed.
Read more
Subjects must have received mepolizumab (Nucala) since authorisation by EMEA in September 2018 (in Spain since December 2019) as an add-on treatment for severe refractory eosinophilic asthma in paediatric patients aged six up to 17 years. The study will be implemented in 16 investigating sites (10 in Spain and 6 in UK). The assignment of a patient to a particular therapeutic strategy is not decided in advance by the study protocol, but is determined by the usual practice of medicine, and the decision to prescribe a particular drug is clearly dissociated from the decision to include the patient in the study.
Eligible participants will meet the local reimbursement criteria. The study will be managed by IQVIA. No patient-identifying information will be transferred to the sponsor nor the CRO.
No visits should be scheduled specifically for this observational study, data will be collected at usual asthma healthcare visits (routine or unscheduled, remote or face to face). If a participant is seen by their physician for monthly mepolizumab injections, data for healthcare utilization, asthma medications and any recent lung function assessment will be collected on a monthly basis. When the participant is seen less frequently by their physician (for example when mepolizumab injection is given at a different site or at home) this data will be collected at usual asthma healthcare visits, which are likely to occur less frequently.
The index date will be defined as the date of the first mepolizumab injection administration during the study (i.e. treatment initiation). To accommodate local healthcare practice, this will be according to local healthcare practice.
- Conditions
- Asthma in Children
- Being tested
- Mepolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MepolizumabDrug
Treatment with Mepoluzimab
| Study group | Role | What they receive |
|---|---|---|
| Treated with Mepolizumab | Not described Receives: Drug: Mepolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the rates of clinically significant asthma exacerbations in the pre-exposure and the 12-month post-exposure period with mepolizumab treatment.
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 posted1 Dec 2021
- Study start2 Mar 2022
- Primary completionMar 2026 (estimated)
- Study completion12 Mar 2026 (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 Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe 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
- Case only
- Time perspective
- Other
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139381
- Sponsor's protocol ID
- 306475
- Acronym
- CASAM
- Status last verified
- Mar 2024
- First submitted
- 17 Nov 2021
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gupta A, de Mir Messa I, Valverde-Molina J, Murray CS, Moral L, Torres Borrego J, Pike K, Diaz-Izquierdo A, Martinez-Canavate A, Nagakumar P, Cook J, Gupta L; CASAM Group. Protocol for an open labelled observational study in children & adolescents with severe asthma with an eosinophilic phenotype treated with mepolizumab (CASAM). PLoS One. 2025 Dec 19;20(12):e0335399. doi: 10.1371/journal.pone.0335399. eCollection 2025.
PubMed 41417800
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Observational Study for Children & Adolescent With Severe Asthma With an Eosinophilic Phenotype Treated With Mepolizumab
- ClinicalTrials.gov ID
- NCT05139381
- Acronym / sponsor ID
- CASAM / 306475
- Conditions
- Asthma in Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- 12 Mar 2026 (estimated)
- First posted
- 1 Dec 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.
Open label, observational cohort study conducted to collect demographics, clinical characteristics and outcome observational data from children (6-17 years) with a clinical diagnosis of severe asthma in 2 countries (Spain and United Kingdom), in public institutions.
All eligible participants who have a physician decision to initiate mepolizumab treatment and are consented for the study will be observed.
Subjects must have received mepolizumab (Nucala) since authorisation by EMEA in September 2018 (in Spain since December 2019) as an add-on treatment for severe refractory eosinophilic asthma in paediatric patients aged six up to 17 years. The study will be implemented in 16 investigating sites (10 in Spain and 6 in UK). The assignment of a patient to a particular therapeutic strategy is not decided in advance by the study protocol, but is determined by the usual practice of medicine, and the decision to prescribe a particular drug is clearly dissociated from the decision to include the patient in the study.
Eligible participants will meet the local reimbursement criteria. The study will be managed by IQVIA. No patient-identifying information will be transferred to the sponsor nor the CRO.
No visits should be scheduled specifically for this observational study, data will be collected at usual asthma healthcare visits (routine or unscheduled, remote or face to face). If a participant is seen by their physician for monthly mepolizumab injections, data for healthcare utilization, asthma medications and any recent lung function assessment will be collected on a monthly basis. When the participant is seen less frequently by their physician (for example when mepolizumab injection is given at a different site or at home) this data will be collected at usual asthma healthcare visits, which are likely to occur less frequently.
The index date will be defined as the date of the first mepolizumab injection administration during the study (i.e. treatment initiation). To accommodate local healthcare practice, this will be according to local healthcare practice.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated with Mepolizumab | – | Drug: Mepolizumab |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 100 paediatric patients (50 per country) using mepolizumab at severe asthma centres in the United Kingdom and Spain over 24-36 months.
Key inclusion criteria (5 listed)
- Patient who provides his/her written informed Consent to participate prior to commencing any study related activities.
- Children \& Adolescent aged 6-17 years at mepolizumab initiation
- Patient with a current clinical diagnosis of severe asthma (as per GINA / ATS / ERS / BTS criteria) and eosinophilic phenotype (as per mepolizumab licence) at mepolizumab initiation
- Patient currently under treatment or who initiates treatment with mepolizumab at the inclusion visit based on national asthma guidelines.
- Patient with relevant paper or electronic-based medical records available for 12-months prior to enrolment date/ index date (date of first mepolizumab injection) for clinically significant asthma exacerbation.
Key exclusion criteria (1 listed)
- A participant will not be eligible for inclusion in this study if any of the following criteria apply: 3. Patient who does not meet the inclusion criteria. 4. Patient who has participated in an asthma monoclonal antibodies drug interventional clinical trial in the previous 12-months to mepolizumab initiation.
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 |
|---|---|---|
| MepolizumabTreatment with Mepoluzimab | Drug | Treated with Mepolizumab |
Primary outcome
To compare the rates of clinically significant asthma exacerbations in the pre-exposure and the 12-month post-exposure period with mepolizumab treatment.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Derived from this study: PubMed 41417800Gupta A, de Mir Messa I, Valverde-Molina J, Murray CS, Moral L, Torres Borrego J, Pike K, Diaz-Izquierdo A, Martinez-Canavate A, Nagakumar P, Cook J, Gupta L; CASAM Group. Protocol for an open labelled observational study in children & adolescents with severe asthma with an eosinophilic phenotype treated with mepolizumab (CASAM). PLoS One. 2025 Dec 19;20(12):e0335399. doi: 10.1371/journal.pone.0335399. eCollection 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 in Children, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
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 1 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: status not confirmed, as of the sponsor's last update on 6 Mar 2024. 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 United Kingdom. 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?
Results are not available in the source record.
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?
To compare the rates of clinically significant asthma exacerbations in the pre-exposure and the 12-month post-exposure period with mepolizumab treatment. (time frame: 12 months). 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 NCT05139381, 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 6 Mar 2024.