NCT03324230

Exploring Asthma Exacerbations in Mepolizumab Treated Patients

Completed Last updated 10 July 2019

What this trial tests

trial in Asthma Brittle in 146 participants. Completed in 29 June 2019.

Timeline

1 December 2017

Primary endpoint
29 June 2019

29 June 2019

Quick facts

Lead sponsor	Queen's University, Belfast
Status	Completed
Study type	OBSERVATIONAL
Enrollment	146
Start date	1 December 2017
Primary completion	29 June 2019
Estimated completion	29 June 2019
Sites	4 locations across United Kingdom

Conditions studied

• Asthma Brittle — all drugs for Asthma Brittle →

Sponsor

Queen's University, Belfast

Who can join

Adults 18 to 80, any sex, with Asthma Brittle. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Characterisation of patients with severe asthma in the UK Severe Asthma Registry in the biologic era.
   Jackson DJ, Busby J, Pfeffer PE, Menzies-Gow A, et al · · 2021 · cited 127× · PMID 33298582 · DOI 10.1136/thoraxjnl-2020-215168
2. The inflammatory profile of exacerbations in patients with severe refractory eosinophilic asthma receiving mepolizumab (the MEX study): a prospective observational study.
   McDowell PJ, Diver S, Yang F, Borg C, et al · · 2021 · cited 85× · PMID 33971168 · DOI 10.1016/s2213-2600(21)00004-7