Inflammation Following Mepolizumab and Oral Corticosteroids in Asthma (MAPLE)

This is an interventional other trial for Asthma focused on measuring Severe asthma, Mepolizumab, IL5, Steroid resistance, Eosinophilic asthma, Type 2 inflammation Read More

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.