The aim is to study the effect of OC000459 on eosinophilic airway inflammation and asthma control in subjects with severe, refractory eosinophilic asthma.
At week 12 subjects not on oral corticosteroids (OCS) will complete the treatment period and return after 4 weeks for final follow up visit. Those subjects who were taking OCS at baseline will continue for a maximum of 12 additional weeks, double blind period during which their current OCS treatment will be titrated down according to their clinical response.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
University of Oxford
Oxford, Oxfordshire, United Kingdom
Compare the effect of OC000459 50mg given once daily with placebo on the induced sputum eosinophil counts.
Time frame: Mean change from baseline and week 12
The effect on pre- and post-bronchodilator spirometry using forced expiratory volume in one second (FEV1).
Time frame: Every 4 weeks up to week 12
The effect of OC000459 on fractional exhaled nitric oxide (FeNO).
Time frame: At 4,8 and 12 weeks
Measuring quality of life using standardised asthma quality of life questionnaire (AQLQ(S)).
Time frame: At weeks 4,8 and 12
Statistical comparison from baseline on induced sputum eosinophil count.
Time frame: At weeks 4,8 and 12
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