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Exploring Asthma Exacerbations in Mepolizumab Treated Patients

NCT03324230 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 146

Last updated 2019-07-10

No results posted yet for this study

Summary

This is a multicentre, observational study focusing on exacerbation events in patients with severe eosinophilic asthma on Mepolizumab.

Mepolizumab is an anti-IL5 (Interleukin 5) monoclonal antibody which blocks the eosinophilic activation pathways associated with decreasing asthma control. The pre-licensing studies have shown that Mepolizumab decreases asthma exacerbation events by approximately 50%, this study seeks to understand the underlying mechanisms of the remaining 50% of exacerbations.

The study will enrol patients within GINA classification 4 and 5 who are known to difficult asthma services across four UK sites. Some patients will recently have been commenced on Mepolizumab, whilst others will be commenced on the drug on entry to the study. The patients will have baseline measurements of biomarkers, lung function, sputum analysis and quality of life questionnaires on study entry, after which patients will be asked to contact the clinic at the first signs of worsening asthma symptoms to arrange a clinic visit prior to commencing rescue treatment. They will be clinically assessed with review of peak flow and symptom diaries, measurements taken at baseline will be repeated and a decision on the nature of the exacerbation and treatment required will be made.

This is an observational study, all outcomes will be exploratory.

Conditions

  • Asthma Brittle

Sponsors & Collaborators

  • RASP (Refractory Asthma Stratification Programme)

    collaborator UNKNOWN

  • Medical Research Council

    collaborator OTHER_GOV

  • University of Oxford

    collaborator OTHER

  • University of Leicester

    collaborator OTHER

  • NHS Greater Glasgow and Clyde

    collaborator OTHER

  • Belfast Health and Social Care Trust

    collaborator OTHER

  • Queen's University, Belfast

    lead OTHER

Principal Investigators

  • Liam Heaney, MB Bch BaO · Queen's University, Belfast

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2019-06-29
Completion
2019-06-29

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03324230 on ClinicalTrials.gov