NCT01057927

Safety and Efficacy Study of OC000459 Dosed Twice Daily for 28 Days in Asthmatic Subjects

Parallel Group, Randomised, Placebo Controlled, Double Blind Oral Assessment of OC000459 Dosed Twice Daily for 28 Days in Asthmatic Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Oxagen Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	OC000459	OC000459 capsules 2x100mg BID for 28 days
DRUG	Placebo	Placebo capsules to match OC000459 100mg capsules, 2 tablets BID

Timeline

• Start date: 2007-01-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2010-01-28
• Last updated: 2010-01-28

Locations

16 sites across 1 country: Russia