Inflammation Following Mepolizumab and Oral Corticosteroids in Asthma

• Status: Completed
• Trial end date: 2020-01-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NHS Greater Glasgow and Clyde
• Collaborator: Queen's University, Belfast
• Treatments: Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Age ≥ 18 and ≤ 80 years at consent.

• Able and willing to provide written informed consent and to comply with the study protocol.

• Severe asthma diagnosis confirmed after assessment by an asthma specialist.

• Suitable for mepolizumab as per NICE/SMC Clinical Guidelines.

Exclusion Criteria:

• Maintenance oral corticosteroid treatment within the past four weeks.

• Acute exacerbation requiring oral corticosteroids in the four weeks prior to consent.

• Other clinically significant medical disease or uncontrolled concomitant disease despite treatment that is likely, in the opinion of the investigator, to require a change in therapy or impact the ability to participate in the study or be significantly worsened by oral corticosteroids.

• History of current alcohol, drug, or chemical abuse or past abuse that would impair or risk the subject's full participation in the study, in the opinion of the investigator.

• Treatment with an investigational agent within 30 days of Visit 1 (or five half-lives of the investigational agent, whichever is longer).

• Women of child-bearing potential who are pregnant, lactating, planning pregnancy during the study period or are unwilling to use a highly effective form of contraception.

• Known hypersensitivity to prednisolone or its excipients.

• Previous psychiatric adverse reactions to steroid therapy in the past.

• Concomitant medication with systemic anti-fungals such as ketoconazole, retinoids, tetracycline, other systemic immunosuppressants e.g. ciclosporin, azathioprine, mycophenolate and live vaccines during the crossover trial.