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The Influence of Inhaled CorticoSteroids Adherence on Treatment Response to Mepolizumab in Severe Eosinophilic Asthma (CSAREA)

U

University Hospitals Birmingham NHS Foundation Trust (UHB)

Status

Unknown

Conditions

Asthma; Eosinophilic

Study type

Observational

Funder types

Other

Identifiers

NCT05241769
RRK7437

Details and patient eligibility

About

The study aim is to look at the effect of the regular use of inhaled corticosteroids on the response and received from mepolizumab treatment which you are receiving or had received before.

Full description

Examine the outcomes of 250 patients who have been treated with mepolizumab within BRSAS and compare the adherence to ICS in the responders and non-responder groups. If confirmed that non-adherence to ICS was related to poor response to mepolizumab, steps then will be undertaken to better monitor and enhance adherence to ICS to improve patients outcomes and response to mepolizumab treatment.

This study will rely on retrospective analysis of medically existing data within the service ,the adherence to ICS treatment will be measured using the prescription possession ratio "PPR" Data is available in the patients' GP records and forms part of the routine clinical practice of the severe asthma clinic to monitor adherence to ICS treatment.

For a significant number of patients ,such data will be already available within patient medical records held at University Hospitals Birmingham NHS Foundation Trust (UHB), however missing data is expected and in such cases GP surgeries will be contacted to obtain the PPR. Patients will be asked to agree to access to GP records as part of the informed consent process.

Enrollment

250 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients of 18 years of age or higher
  • Patients commenced on mepolizumab within the BRSAS network
  • Patients who have at least 1 mepolizumab injection and with at least 3 months follow-up data from the time of treatment initiation
  • Patients must be able and willing to give informed consent to participate in the study . An Interpreter will be provided for those patients where English is not their first language.

Exclusion criteria

  • Refusal or inability to provide informed consent

Trial contacts and locations

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Central trial contact

Adel Mansur

Data sourced from clinicaltrials.gov

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