Asthma Respiratory Asthma
Conditions
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,
Sponsors
University Hospitals of Leicester NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
United Kingdom
Outcome results
None listed