Safety and Efficacy Study of OC000459 Dosed Twice Daily for 28 Days in Asthmatic Subjects
- Registration Number
- NCT01057927
- Lead Sponsor
- Oxagen Ltd
- Brief Summary
The purpose of the study is to investigate the clinical effects of multiple (28 day) twice-daily doses of OC000459 in comparison to placebo on clinic lung function (FEV1) in mild to moderate asthmatics with an FEV1 of 60-80% of predicted and requiring only short acting inhaled B2-adrenergic agonists for symptomatic control.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 132
Not provided
- Use of inhaled or local corticosteroids in the period from 28 days prior to screening.
- Receipt of prescribed or over the counter medication within 14 days of the first study day.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OC000459 OC000459 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Forced expiratory volume in one second (FEV1) 28 days
- Secondary Outcome Measures
Name Time Method Clinic peak expiratory flow, diary peak expiratory flow, diary asthma symptoms, diary salbutamol use, Asthma Quality of Life Questionnaire (AQLQ(S)) 28 days Sputum eosinophilia (subset of patients) and serum IgE 28 days Safety and tolerability assessed by adverse events, chest examination, concomitant medication and laboratory safety parameters 28 days
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (15)
Sverdlovsk Regional Hospital #1
🇷🇺Ekaterinburg, Russian Federation
Research Institute of Pulmonology
🇷🇺Moscow, Russian Federation
Burdenko Main Military Hospital
🇷🇺Moscow, Russian Federation
City Hospital #23
🇷🇺Moscow, Russian Federation
City Hospital #7
🇷🇺Moscow, Russian Federation
Vishnevsky Central Military Hospital #3
🇷🇺Moscow, Russian Federation
Leningrad Regional Hospital
🇷🇺St Petersbrug, Russian Federation
St George City Hospital
🇷🇺St Petersburg, Russian Federation
St Petersburg Medical Academy of Postgraduate Education
🇷🇺St Petersburg, Russian Federation
St Petersburg Medical Academy
🇷🇺St Petersburg, Russian Federation
Scroll for more (5 remaining)Sverdlovsk Regional Hospital #1🇷🇺Ekaterinburg, Russian Federation