Effect of mepolizumab in severe bilateral nasal polyps
A randomised, double-blind, parallel group PhIII study to assess the clinical efficacy and safety of 100 mg SC Mepolizumab as an add on to maintenance treatment in adults with severe bilateral nasal polyps
Duration of Study in the UK
2 years, 1 months, 13 days
Nasal polyposis (NP) is a chronic inflammatory disease of the lining of inside of the nose. It causes soft tissue overgrowth in the nose cavity which causes symptoms like nasal blockage, disturbed smell and pain. Although many patients with NP can be treated with medication (corticosteroids / antibiotics), often an operation is needed. It is already known that eosinophils (a type of white blood cell) are involved in nasal polyp creation. NP sufferers have high levels of blood eosinophils.
GSK is conducting a study to test how safe and effective a medicine called mepolizumab is at treating nasal polyps. Mepolizumab interferes with eosinophil activation and reduces their numbers, which could affect NP.
In this study, severe bilateral NP participants will be randomized into one of two treatment groups; either 100 mg mepolizumab (under the skin) plus usual package of care, or to placebo (a dummy drug, given in the same way) alongside usual care - every 4 weeks for 13 doses. This study is ‘double blind’ (neither the patient nor the investigators know whether the patient is receiving mepolizumab or placebo).
The participant will visit the clinic 15 times. The first visit will review the subjects medical/NP history, physical exam, vital signs, ECG (heart electric activity recorded), urine pregnancy test (if applicable), camera examination of the nasal passages and nasal symptom questionnaire completion plus a blood sample to look at organ function/viruses taken. At all other visits the subjects will complete 5 questionnaires, plus 2 symptom score reviews, vital signs and a blood sample taken. At Visit 2 and 15 a nasal secretion sample will be collected plus an ECG performed. Daily completion of a symptom eDiary is necessary.
The first 200 subjects will be followed up bi-monthly for 6 further months.
We plan to recruit 20 UK participants.
East Midlands - Derby Research Ethics Committee
Date of REC Opinion
20 Jun 2017
Further Information Favourable Opinion