GSK RESPONSE
Research type
Research Study
Full title
RESPONSE: REal world non-interventional prospective multi-country Study of mePOlizumab in patients with chronic rhinosinusitis with Nasal polyposis and asthma or Severe Eosinophilic asthma and nasal polyps
IRAS ID
334755
Contact name
Thomas Brown
Contact email
Sponsor organisation
GSK, GSK Medicines Research Centre
Duration of Study in the UK
1 years, 5 months, 15 days
Research summary
Severe asthma is a condition consisting of its various subtypes including eosinophilic asthma. Severe eosinophilic asthma (SEA) has significant morbidity including an increase in emergency room (ER) visits and a decrease in productivity due to missed school and workdays which results in significant economic burden.
Nasal polyposis (NP) is a chronic inflammatory disease of the sinuses that can cause severe nasal symptoms and systemic symptoms including fatigue, difficulty sleeping, and impairments in social, emotional, and overall well-being.
Mepolizumab is a humanised monoclonal antibody used for the treatment of SEA as an add-on therapy and was recently approved as an add-on treatment for patients with Chronic rhinosinusitis with nasal polyposis (CRSwNP).
Mepolizumab has been added to the international guidelines for CRSwNP standard of care (SoC) and is the first anti-interleukin-5 biologic treatment for CRSwNP approved in Europe.
This study aims to, for the first time, to assess the effectiveness of mepolizumab in patients with severe asthma and NP, as well as patients with CRSwNP and any severity of comorbid asthma, looking at both asthma and NP related outcomes.
While the effectiveness of mepolizumab is well-documented to reduce severe asthma exacerbations among SEA patients, evidence is limited on the effectiveness of
mepolizumab use in patients with CRSwNP in a standard of care, daily setting.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
24/EM/0051
Date of REC Opinion
4 Mar 2024
REC opinion
Further Information Favourable Opinion