NCT00890877

OC000459 Dose Finding Study in Patients With Mild to Moderate Persistent Asthma

Dose Finding Study in Patients With Mild to Moderate Persistent Asthma: A Parallel Group, Randomised, Placebo Controlled, Double Blind Assessment of Oral Oc000459 Dosed At Three Dose Schedules for Twelve Weeks Finding Study In Patients With Mild To Moderate Persistent Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Oxagen Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mild to Moderate Persistent Asthma

Interventions

Type	Name	Description
DRUG	OC000459 or placebo	Pills, active and/or placebo given twice daily for 17 weeks

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-05-01
• Completion: 2010-07-01
• First posted: 2009-04-30
• Last updated: 2010-09-02

Locations

6 sites across 6 countries: Bulgaria, Hungary, Poland, Romania, Russia, Ukraine