OC000459 in Severe Asthma
Research type
Research Study
Full title
THE EFFECT OF OC000459 ON EOSINOPHILIC AIRWAY INFLAMMATION AND ASTHMA CONTROL IN SUBJECTS WITH REFRACTORY EOSINOPHILIC ASTHMA: A RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED TRIAL
IRAS ID
183198
Contact name
Ian Pavord
Contact email
Sponsor organisation
Atopix Therapeutics Ltd
Eudract number
2015-001833-26
Duration of Study in the UK
1 years, 6 months, days
Research summary
This study will compare the effects of oral OC000459 50 mg daily with placebo on induced sputum eosinophil counts, symptoms, quality of life and other measures of disease activity and severity in subjects with severe asthma and evidence of active eosinophilic airway inflammation.
Subjects will meet standard criteria for a diagnosis of severe asthma and have historical evidence of eosinophilic airway inflammation.
The randomised treatment period will last for 12 weeks for subjects not taking oral corticosteroids (OCS) and 24 weeks for subjects taking OCS. The treatment will be the same for each group of patients during the first 12 weeks of the study. Those patients taking OCS at baseline (20mg prednisolone or less daily for the 4 weeks prior to randomisation) will continue into a second 12 week phase where their OCS therapy will be stepped down based on their asthma control.
All subjects will attend their final follow up visit 4 weeks after completing randomised treatment after which they will be discharged from the trial.
Subjects will be asked to consent to an optional evaluation of airway inflammation as determined by bronchoscopy.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
15/SC/0404
Date of REC Opinion
21 Jul 2015
REC opinion
Favourable Opinion