Clinical trial NCT05241769: The Influence of Inhaled CorticoSteroids Adherence on Treatment Response to Mepolizumab in Severe Eosinophilic Asthma
Official title: The Influence of Inhaled CorticoSteroids Adherence on Treatment Response to Mepolizumab in Severe Eosinophilic Asthma (CSAREA Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma; Eosinophilic
Lead sponsor: University Hospital Birmingham
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Birmingham Regional Severe Asthma

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: To assess the influence of inhaled corticosteroids (ICS) adherence on treatment response to mepolizumab in severe eosinophilic asthma
timeFrame: 20 months
Secondary outcomes:
measure: to describe baseline demographic and clinical characteristics of severe eosinophilic asthma patients treated with mepolizumab in the BRSAS network
timeFrame: 20 months
measure: To describe the overall response and clinical outcomes to mepolizumab therapy in the BRSAS population.
timeFrame: 20 months
measure: to measure the frequency of severe exacerbations requiring oral corticosteroids treatment in patients treated with mepolizumab in patients with high/low fraction exhaled nitric oxide groups.
timeFrame: 20 months
measure: To determine the response rate to mepolizumab in FeNO high and FeNO low groups (using variable cut off levels).
timeFrame: 20 months
measure: To investigate the relationship between FeNO and ICS dose in patients on mepolizumab treatment.
timeFrame: 20 months
measure: To investigate the relationship between the prescription possession ratio (PPR) of inhaled corticosteroids (ICS) and FeNO level in patients on mepolizumab treatment.
timeFrame: 20 months
measure: To determine the mepolizumab response rate in the ICS adherent versus non-adherent patients (at 70% ICS PPR cut off level).
timeFrame: 20 months
measure: To compare mean inhaled corticosteroids (ICS) daily dose and prescription possession ratio (PPR) in the period before and on mepolizumab treatment.
timeFrame: 20 months
measure: To explore patient characteristics and predictors of poor ICS adherence
timeFrame: 20 months
Other outcomes:
Locations:
Study officials:
affiliation: UHB
name: Adel Mansur
role: STUDY_DIRECTOR
References: