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Mepolizumab and exacerbation frequency in refractory eosinophilic asthma: a randomised, double blind, placebo controlled trial
ISRCTN ISRCTN75169762
DOI 10.1186/ISRCTN75169762
ClinicalTrials.gov identifier
EudraCT number
Public title Mepolizumab and exacerbation frequency in refractory eosinophilic asthma: a randomised, double blind, placebo controlled trial
Scientific title
Acronym N/A
Serial number at source 125770
Study hypothesis Mepolizumab which is a monoclonal antibody against interleukin 5, will effectively suppress eosinophilic airway inflammation and lower exacerbation frequency in severe asthmatics with evidence of persistent eosinophilic airway inflammation and a history of recurrent asthma exacerbations (greater than or equal to 2/year).

The hypothesis is based upon previous studies that have demonstrated a temporal relationship between a rise in sputum eosinophilia predicting onset of exacerbations. Steroid therapy targeted at lowering sputum eosinophil counts have been effective in lowering exacerbation frequency. Following on from this, mepolizumab has been shown in pilot studies to be effective in lowering both blood and sputum eosinophil counts and if the previous observations are robust in their hypothesis that sputum eosinophilia is causally related to asthma exacerbations, then we would expect mepoloizumab to achieve control of exacerbations through its mechanism of action. The present study has been designed to test this hypothesis.
Lay summary
Ethics approval Obtained before recruitment of the first participant.
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Asthma
Participants - inclusion criteria 1. 60 participants meeting American thoracic criteria for refractory asthma
2. On intensive corticosteroid therapy - either oral and/or inhaled
3. A history of two or more exacerbations of asthma requiring oral corticosteroid rescue therapy in one year
4. Evidence of persistent eosinophilic inflammation in sputum - sputum eosinophils greater than 3% of total cell count
Participants - exclusion criteria 1. Participants who do not meet American Thoracic Society criteria for severe asthma
2. Participants who have not demonstrated evidence of persistent eosinophilic airway inflammation (sputum eosinophil counts of greater than or equal to 3% of total cell count
3. Partcipants who are current smokers or who have a cumulative smoking history of greater than 15 pack years
4. Participants with significant co morbidity - including other symptomatic respiratory diagnoses, evidence of recurrent bacterial respiratory tract infections (greater than or equal to 2 per year), symptomatic ischaemic heart disease and mental health or other conditions that interfere with participant compliance with the study
5. Pregnant females or women of child bearing age not practising effective contraception during the study
Anticipated start date 01/08/2005
Anticipated end date 31/07/2007
Status of trial Completed
Patient information material
Target number of participants 60
Interventions 12 month randomised double blind placebo contolled parallel group trial to receive either placebo or monoclonal antibody therapy to interleukin 5 (mepolizumab) - 750 mg intravenously over 30 minutes, monthly.
Primary outcome measure(s) Sputum eosinophil counts measured every 3 months and exacerbation frequency over the 12 month treatment period. We have 80% power to detect a 50% change in exacerbation frequency over 1 year for a total of 60 trial participants.
Secondary outcome measure(s) 1. Asthma symptoms and quality of life
2. Computed tomography (CT) and bronchial biopsy evidence of airway remodelling (i.e. structural changes to the airway wall from long standing chronic airway inflammation)
Sources of funding 1. University Hospitals of Leicester NHS Trust (UK)

Added as of 02/01/2008:
2. GlaxoSmithKline (UK)
Trial website
Publications 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19264686
Contact name Prof  Ian  Pavord
  Address Glenfield Hospital
Groby Road
  City/town Leicester
  Zip/Postcode LE3 9QP
  Country United Kingdom
Sponsor University Hospitals of Leicester NHS Trust (UK)
  Address Glenfield Hospital
Groby Road
  City/town Leicester
  Zip/Postcode LE3 9QP
  Country United Kingdom
  Sponsor website: http://www.uhl-tr.nhs.uk/
Date applied 04/05/2005
Last edited 10/03/2009
Date ISRCTN assigned 10/08/2005
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