EUCTR2005‐001932‐61‐GB

Trial name or title	Mepolizumab and exacerbation frequency in refractory eosinophilic asthma. A randomised, double blind, placebo controlled, parallel group trial
Methods	Randomised, double‐blind, placebo‐controlled, parallel‐group trial
Participants	Target recruitment = 60 participants with refractory eosinophilic asthma Principal inclusion criteria Refractory asthma as defined by the American Thoracic Society guidelines Symptoms and objective evidence of variable airflow obstruction as indicated by one or more of the following: > 15% increase in FEV1 following 200 μg inhaled salbutamol > 20% within‐day variability in PEFR noted on any day following assessment twice‐daily over 2 weeks and/or a concentration of methacholine causing 20% fall in FEV1 of < 8 mg/mL documented at any time during previous assessments at Glenfield Hospital A history of ≥ 2 asthma exacerbations in the previous 12 months requiring oral corticosteroids on at least 3 consecutive days, emergency care visit and treatment or hospitalisation Evidence of eosinophilic airway inflammation ‐ a sputum eosinophil count of > 3% in last 2 years
Interventions	Mepolizumab IV Placebo
Outcomes	Main objective To investigate whether mepolizumab effectively suppresses the presence of eosinophils in sputum and whether this translates into a fall in the frequency of asthma exacerbations in a cohort of refractory asthmatics who otherwise require a high dose of inhaled corticosteroids and, in some cases, regular oral corticosteroids to control their asthma. Secondary objectives To assess the effects of mepolizumab on: long‐term changes in airway structure and function (airway remodelling) after 12 months' treatment using bronchial biopsy material and CT scans asthma symptoms and quality of life, analysed using diary cards and validated questionnaires exhaled nitric oxide levels concentration of methacholine required to cause a fall in FEV1 by 20% from baseline Hospital admission rates over the 12 months Obtain blood samples for pharmacogenomic analysis by GSK (N.B. This does not form part of the data collection/analysis of this study)
Starting date	Date of competent authority/ethics committee decision 2005‐11‐16
Contact information	(No contact details listed) Sponsored by University Hospitals of Leicester www.clinicaltrialsregister.eu/ctr‐search/trial/2005‐001932‐61/GB
Notes	Non‐commercial