OC000459 Dose Finding Study in Patients With Mild to Moderate Persistent Asthma
Phase 2
Completed
- Conditions
- Mild to Moderate Persistent Asthma
- Interventions
- Drug: OC000459 or placebo
- Registration Number
- NCT00890877
- Lead Sponsor
- Oxagen Ltd
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 480
Inclusion Criteria
- Male or female asthmatics, any racial group. Females of childbearing potential must practise two forms of contraception
- Aged 18 to 55 years inclusive.
- Non smokers for at least the past 12 months with a pack history of less than 10 pack years.
- Mild to moderate persistent asthma according to GINA4 guidelines for at least 12 months
Exclusion criteria:
- Receipt of prescribed or over the counter medication within 14 days prior to the first study day
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 OC000459 or placebo - 3 OC000459 or placebo - 1 OC000459 or placebo - 4 OC000459 or placebo -
- Primary Outcome Measures
Name Time Method Forced expiratory volume in one second (FEV1) 17 weeks
- Secondary Outcome Measures
Name Time Method Asthma quality of life questionnaire (AQLQ) 17 weeks
Trial Locations
- Locations (1)
Research site
🇺🇦Kiev, Ukraine