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

NCT05139381 | Active Not Recruiting DMC

• 1 other identifier: 306475
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (1)

• To compare the rates of clinically significant asthma exacerbations in the pre-exposure and the 12-month post-exposure period with mepolizumab treatment.

  12 months

Study Arms (1)

Treated with Mepolizumab

Drug: Mepolizumab

Interventions

Mepolizumab DRUG

Treatment with Mepoluzimab

Treated with Mepolizumab

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

100 paediatric patients (50 per country) using mepolizumab at severe asthma centres in the United Kingdom and Spain over 24-36 months.

You may qualify if:

• 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 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.

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 41417800 DERIVED

MeSH Terms

Interventions

mepolizumab

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 1, 2021
• Study Start: March 2, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 12, 2026
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

GB (1)