NCT03610685

Inflammation Following Mepolizumab and Oral Corticosteroids in Asthma

Persistence of Inflammation and Study of T2 Pathways Following Inhibition of InterLeukin-5 With Mepolizumab in Severe Eosinophilic Asthma

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: NHS Greater Glasgow and Clyde · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The aim of the project is to study the persistence of inflammation after addition of an interleukin-5 (IL-5) blocker in severe eosinophilic asthma as a study of untreated pathways in these patients.

Detailed description

Mepolizumab, a humanized monoclonal antibody (mAb) antagonizes IL-5 and through a selective inhibition of eosinophilic inflammation, reduces the number of eosinophils in sputum and blood, leading to a reduction in asthma exacerbations and a need for systemic glucocorticoids. Once this therapy has been initiated for severe eosinophilic asthma, the additional role of oral corticosteroids is questionable as their main target is reduction of eosinophils and hence responsiveness to oral corticosteroids in patients in a stable state of asthma may reduce. Using two weeks of high dose prednisolone versus placebo in a crossover design after 12 weeks of mepolizumab therapy will allow an understanding of the pathways that remain steroid responsive following IL-5 suppression. This is an exploratory study with no single primary end point. The objective of the study is to assess the change in airway inflammation following oral corticosteroids versus placebo and the airway inflammation while on mepolizumab in stable state of asthma. Note: Mepolizumab is not an intervention in this study; it is initiated as part of usual NHS care.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Prednisolone	Given daily for 2 weeks
DRUG	Placebo oral capsule	Given daily for 2 weeks

Timeline

• Start date: 2018-10-19
• Primary completion: 2020-01-07
• Completion: 2020-01-07
• First posted: 2018-08-01
• Last updated: 2020-03-06

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study