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

NCT05241769 | Unknown DMC

• 1 other identifier: RRK7437
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma; Eosinophilic

Outcome Measures

Primary Outcomes (1)

• To assess the influence of inhaled corticosteroids (ICS) adherence on treatment response to mepolizumab in severe eosinophilic asthma

  We will measure the adherence to inhaled corticosteroids treatment (ICS) during the period when patients were treated with the biologic treatment mepolizumab. Adherence to ICS will be measured in the form of prescription possession ratio (PPR) in which the number of prescription picked up by patients is divided by the expected number to be used in a specified period of time (one year). Adherence will be defined as a PPR of =\>70%. Mepolizumab responser group will be defined as those achieving reduction in the use of maintenance oral corticosteroids (OCS) and/or frequency of severe asthma exacerbations require OCS treatment by =\>50%. The adherence rates to ICS as measured by PPR in the mepolizumab responder and non-responder groups will be compared to find out if ICS non-adherence reduce response to meplizumab treatment in patients with severe eosinophilic asthma

  20 months

Secondary Outcomes (9)

• to describe baseline demographic and clinical characteristics of severe eosinophilic asthma patients treated with mepolizumab in the BRSAS network

  20 months

• To describe the overall response and clinical outcomes to mepolizumab therapy in the BRSAS population.

  20 months

• 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.

  20 months

• To determine the response rate to mepolizumab in FeNO high and FeNO low groups (using variable cut off levels).

  20 months

• To investigate the relationship between FeNO and ICS dose in patients on mepolizumab treatment.

  20 months

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Birmingham Regional Severe Asthma

You may qualify if:

• 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.

You may not qualify if:

• Refusal or inability to provide informed consent

Sponsors & Collaborators

• University Hospital Birmingham: lead

MeSH Terms

Conditions

Pulmonary Eosinophilia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Adel Mansur

  UHB

  STUDY DIRECTOR

Central Study Contacts

Adel Mansur

CONTACT

01214241731; adel.mansur@uhb.nhs.uk

Study Design

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

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 16, 2022
• Study Start: March 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share