CWoW - MATINEE: A Phase 3 study of Mepolizumab in patients with COPD
Research type
Research Study
Full title
A multi-center, randomized, double-blind, parallel-group, placebo controlled study of mepolizumab 100 mg SC as add-on treatment in participants with COPD experiencing frequent exacerbations and characterized by eosinophil levels (Study 208657)
IRAS ID
265640
Contact name
Glenn Cardwell
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2018-001540-56
Clinicaltrials.gov Identifier
IND Number, 006971
Duration of Study in the UK
2 years, 6 months, 22 days
Research summary
Chronic obstructive pulmonary disease (COPD) is a term used to describe progressive lung diseases including emphysema (damage to the air sacs in the lungs) and chronic bronchitis (long-term inflammation of the airways). COPD is punctuated by periods of acute exacerbations (worsening symptoms) such as shortness of breath, quantity and colour of phlegm. There is currently no cure and treatment guidelines recommend the use of inhalers, which relax muscles around the airways.
Previous studies have shown Mepolizumab to have an effect on exacerbation reduction in participants with COPD who frequently exacerbate despite treatment with standard of care inhalers. It has been observed that inflammation driven by increased eosinophils (a type of white blood cell) is associated with a specific type of COPD. Eosinophils release toxic proteins that cause bronchial damage and airflow obstruction. Mepolizumab can reduce eosinophils.
This study will evaluate the efficacy and safety of Mepolizumab compared to placebo in COPD participants, characterised by increased eosinophil levels, at high risk of exacerbations despite the use of optimised COPD maintenance therapy. The study is designed to confirm the benefits of mepolizumab compared to placebo on reducing moderate/severe exacerbations.
Participants will be randomly assigned in a 1:1 ratio to receive either mepolizumab or placebo by subcutaneous injection every 4 weeks for a period of 52 weeks (13 doses). Participants will have 16 visits to the site in total and will be required to complete questionnaires on an electronic Diary at home.
Procedures include: physical examinations, vital signs, electrocardiograms, urine and blood samples for laboratory tests, lung function tests (spirometry)and quality of life and respiratory questionnaires.
This study is sponsored by GlaxoSmithKline. Approximately 800 participants will take part in the study and 91 of those are expected in the UK.
REC name
North West - Haydock Research Ethics Committee
REC reference
19/NW/0305
Date of REC Opinion
5 Aug 2019
REC opinion
Further Information Favourable Opinion