An observational study in Asthma in Children, sponsored by King's College Hospital NHS Trust. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by King's College Hospital NHS Trust · Observational
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.
3,921 studies on the registry are indexed under Asthma; 506 are open to participants now.
This study's enrollment of 148 is close to the median of 150 across 970 observational studies indexed under Asthma.
Browse Asthma studies →King's College Hospital NHS Trust is the lead sponsor of 165 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
100 paediatric patients (50 per country) using mepolizumab at severe asthma centres in the United Kingdom and Spain over 24-36 months.
Exclusion Criteria:
Drug: Mepolizumab
Treatment with Mepoluzimab
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
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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King's College Hospital NHS Trust