A study to observe the normal use of Nucala® and its effectiveness
Research type
Research Study
Full title
A Multinational, Single Arm, Observational Study to Evaluate the Real-world Effectiveness and Pattern of Use of Mepolizumab in Patients with Severe Eosinophilic Asthma (204710)
IRAS ID
216249
Contact name
Rekha Chaudhuri
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Ltd.
Clinicaltrials.gov Identifier
IND Number, 006971
Duration of Study in the UK
3 years, 11 months, 10 days
Research summary
Summary of Research
This is an observational study for patients with severe eosinophilic asthma whose disease remains poorly controlled, despite treatment with corticosteroids (CS) in combination with other asthma medications.
Patients with severe asthma have more frequent asthma ‘attacks’, a greater need for medical care and are twice as likely to experience impairments in their everyday life compared to patients with moderate or mild disease. Moreover, whilst CS are effective in reducing asthma ‘attacks’, frequent use of CS may cause other medical problems, such as mood swings, weight gain, acne, diabetes and high blood pressure. Therefore, there is a clinical need to minimise CS use and opt for alternative treatment modalities, where medically possible.
Asthma is an inflammatory disease of the airways, which can have many different causes and may present itself in many forms, depending on the underlying biological processes. Previous studies have shown that eosinophils, a type of white blood cells (WBC), play an important role in the airway inflammation in patients with severe asthma. These WBCs are predominantly activated by a cytokine (a small cell-signalling protein) called Interleukin 5 (IL-5). Mepolizumab is an antibody that binds with IL-5, thus preventing this cytokine from activating the eosinophils. The safety and effectiveness of Mepolizumab has previously been demonstrated in RCTs. It has recently been launched (by GlaxoSmithKline as Nucala®) for the treatment of severe asthma.
This research is a-multi-centre, observational, post-marketing registry study and does not involve any interventional research procedures. Patients who have been prescribed Nucala® in line with national guidance and as part of their normal care, who are otherwise eligible and willing to take part, will be observed for 24 months. Only clinical and laboratory data from routine healthcare visits will be collected. Participants will be asked to complete 2 health-related questionnaires at baseline, months 12 and 24.REC name
South East Scotland REC 02
REC reference
16/SS/0224
Date of REC Opinion
11 Jan 2017
REC opinion
Further Information Favourable Opinion