This will be a double blind, randomised, 4 arm, parallel group, placebo controlled study of three dose levels of OC000459 tablets in patients with asthma controlled by beta agonist drugs alone. This study will compare the patients on OC000459 at three different dose levels (25mg once daily, 100mg twice daily and 200mg once daily) with patients on placebo after dosing for 17 weeks. The trial will be undertaken in an outpatient population. Each treatment arm will consist of at least 110 subjects. The objective is to assess the efficacy of these dose levels on the patients asthma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
480
Pills, active and/or placebo given twice daily for 17 weeks
Research site
Sofia, Bulgaria
Research site
Győr, Hungary
Research site
Warsaw, Poland
Research site
Bucharest, Romania
Research site
Moscow, Russia
Forced expiratory volume in one second (FEV1)
Time frame: 17 weeks
Asthma quality of life questionnaire (AQLQ)
Time frame: 17 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research site
Kiev, Ukraine