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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Safety and Efficacy Study of Mepolizumab in Subjects With Severe Asthma

NCT03562195

Asthma

COMPLETED PHASE3

A Study to Evaluate the Effect of a Single-Dose Intravenous Administration of MEDI-528

NCT00483041

Asthma

TERMINATED PHASE2

Effect of Mepolizumab on Severe Eosinophilic Asthma

NCT04641741

Asthma Eosinophilic Asthma

UNKNOWN

Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma

NCT01691521

Asthma

COMPLETED PHASE3

Mepolizumab Steroid-Sparing Study in Subjects With Severe Refractory Asthma

NCT01691508

Asthma

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma; Eosinophilic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.