None listed
Conditions
Brief summary
The use of biologic medications (including mepolizumab and dupilumab) has demonstrated success in the management of eosinophilic asthma. Anecdotal experience with mepolizumab and dupilumab in a well defined group of chronic rhinosinusitis patients with eosinophilic inflammation has been very positive. This study assesses the effect of biologic medication in nasal polyp eosinophilia, in particular, aiming to demonstrate the effect of these treatments of respiratory mucosal eosinophilic inflammation at the tissue level, in addition to the serum eosinophil level. This study aims to assess factors that may contribute to treatment success and failure including tissue histopathology, serum/blood biomarkers including blood eosinophils, assessment of recorded endoscopy and patient reported clinical improvement based on patient reported outcome measures. This study would provide evidence of the direct tissue response to biologic medication, provide a relationship between tissue and serum levels and might provide prognostic information to responders to therapy.
Interventions
Mepolizumab 100mg subcutaneous injection will be administered by study investigators every 4 weeks for 6 months. Patients will be reviewed on every visit (every 4 weeks for 6 months) and 3 months following completion of therapy .
Arm A: Mepolizumab 100mg subcutaneous injection will be administered by study investigators every 4 weeks for 6 months. Patients will be reviewed on every visit (every 4 weeks for 6 months) and 3 months following completion of therapy.
Arm B: Dupilumab 600mg loading then 300mg subcutaneous injection administered every two weeks (alternating between study investigators and self-administered by patients). Patients will be reviewed on every visit (every 4 weeks for 6 months) and 3 months following
Arm A: Mepolizumab 100mg subcutaneous injection will be administered by study investigators every 4 weeks for 6 months. Patients will be reviewed on every visit (every 4 weeks for 6 months) and 3 months following completion of therapy. Arm B: Dupilumab 600mg loading then 300mg subcutaneous injection administered every two weeks (alternating between study investigators and self-administered by patients). Patients will be reviewed on every visit (every 4 weeks for 6 months) and 3 months following completion of therapy.
Sponsors
Richard Harvey
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patients with severe nasal polyp disease or eosinophilic chronic rhinosinusitis Not currently receiving mepolizumab treatment Patients who do not meet the PBS criteria for severe lower airway disease Body weight: A minimum body weight >=40 kilograms (kg) at Visit 1 Gender: Male or female. Informed consent: Capable of giving signed informed consent
Exclusion criteria
Subjects with known hypersensitivity to mepolizumab Subjects with other conditions that could lead to elevated eosinophils such as Hypereosinophilic Syndromes, including Churg-Strauss Syndrome, or Eosinophilic Esophagitis. Subjects with known immunodeficiency Subjects with cystic fibrosis
Outcome results
None listed