Study to evaluate a mepolizumab autoinjector in severe asthma
Research type
Research Study
Full title
An open-label, single arm, repeat dose, multi-centre study to evaluate the use of an autoinjector for the subcutaneous administration of mepolizumab in subjects with severe eosinophilic asthma (study 204959)
IRAS ID
224298
Contact name
Ian Pavord
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2016-001832-36
Duration of Study in the UK
0 years, 9 months, 3 days
Research summary
Mepolizumab interferes with eosinophil activation and multiplication, which could affect eosinophilic asthma. To make administration of mepolizumab easier, a subcutaneous (SC) ‘auto-injector’ syringe has been developed. The aim of this study is to assess how easy patients / caregivers find it to use the auto-injector correctly.
In this study - after appropriate training - severe eosinophilic asthmatics will self-administer 100mg mepolizumab SC as a single injection into the thigh, abdomen or upper arm on three occasions every 4 weeks for 12 weeks. They will first self-inject at visit 2, under observation by the clinical staff. The staff will assess how well the participant self–administered. The second dose will be self-administered at home within 24 hours of visit 3, following which the participant will complete a checklist to confirm they administered the mepolizumab correctly. At visit 4 they will self-administer under observation at the clinic. Following each self-administration the participants will complete a visual analogue scale to assess pain at the injection site (via an eDiary) at 0hr, 1hr and 24hrs post the injection.
The participant will visit the clinic 6 times over 18 weeks. The first visit will review the participants’ medical/asthma history, involve a physical examination / vital signs assessment, ECG (heart electric activity), urine pregnancy test (if applicable), and a blood sample to look at organ function/viruses will be taken. At all other visits the participants will have their vital signs checked and a blood sample (approximately 1 teaspoon) taken. At the final visit the participant will have an ECG and physical exam, plus a short survey regarding the patient’s views of the auto-injector treatment.
We plan to recruit 12 UK participants and 150 patients globally. GSK is sponsoring this study.
REC name
London - Riverside Research Ethics Committee
REC reference
17/LO/0504
Date of REC Opinion
15 May 2017
REC opinion
Further Information Favourable Opinion