Study for Children & Adolescent With Severe Asthma With an Eosinophilic

Status Active, not recruiting

Clinical 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. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05139381
Study type	Observational
Source	King's College Hospital NHS Trust
Contact
Status	Active, not recruiting
Phase
Start date	March 2, 2022
Completion date	March 12, 2026

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Study for Children & Adolescent With Severe Asthma With an Eosinophilic Phenotype Treated With Mepolizumab — CASAM

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms