Effect of mepolizumab in eosinophilic chronic rhinosinusitis
The effect of mepolizumab on patients with nasal polyp eosinophilia
Richard Harvey
20 participants
May 29, 2019
Interventional
Conditions
Summary
The use of Mepolizumab has demonstrated success in the management of eosinophilic asthma. Anecdotal experience with mepolizumab in a well defined group of chronic rhinosinusitis patients with eosinophilic inflammation has been very positive. This study assesses the effect of mepolizumab in nasal polyp eosinophilia, in particular, aiming to demonstrate the effect of mepolizumab treatment 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 mepolizumab, provide a relationship between tissue and serum levels and might provide prognostic information to responders to therapy.
Eligibility
Inclusion Criteria6
- 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 Criteria4
- 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
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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 .
Locations(1)
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ACTRN12618000113257