CASAM

• Research type

  Research Study

• Full title

  Open Label, Observational Study for Children & Adolescent with Severe Asthma with an Eosinophilic Phenotype Treated with Mepolizumab. CASAM STUDY.

• IRAS ID

  306475

• Contact name

  Latika Gupta

• Contact email

  latika.gupta@kcl.ac.uk

• Sponsor organisation

  King's College Hospital NHS Foundation Trust

• Clinicaltrials.gov Identifier

  NCT05139381

• Clinicaltrials.gov Identifier

  NA, NA

• Duration of Study in the UK

  4 years, 0 months, 1 days

• Research summary

  Rationale:
  The purpose of this ‘real-world’ observational study in children & adolescents is to generate evidence which is complementary to that produced by previous clinical trials. This study will assess the use of mepolizumab in a more heterogeneous population, including patients with a broader spectrum of co-morbidities and concomitant medications than would typically be allowed in clinical studies.

  Study design:
  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.

  Primary objective:
  To compare the rates of clinically significant asthma exacerbations in the pre-exposure and the 12-month post-exposure period with mepolizumab treatment. A clinically significant asthma exacerbation is defined as deterioration in asthma requiring (1) use of systemic corticosteroids and/or (2) emergency department (ED) visit and/or hospital admission.

  Study Population:
  Intention to recruit 100 paediatric patients (50 per country) using mepolizumab at severe asthma centres in the United Kingdom and Spain over 24-36 months. Mepolizumab therapies may be added on to existing treatments. Prior use of other biological medications will be allowed.

  Patient recruitment will be competitive in both countries and will last minimum until 100 patients are recruited.
  Patients will be invited to participate in this study during a routine medical visit for any purpose with their physician, and the patient will be considered included when he/she agrees to participate in the study by signing the informed consent and if all of the selection criteria are met(see inclusion and exclusion criteria in protocol).

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  21/PR/1651

• Date of REC Opinion

  14 Jan 2022

• REC opinion

  Further Information Favourable Opinion