drugset / Trial / NCT01057927

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

NCT01057927 ↗

Phase 2 Completed 132 enrolled Oxagen Ltd
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2007-01
Primary completion
2007-11
Completion
2007-11

Outcome

Missed primary endpoint

paper In the FA population, the mean change in FEV(1) was 7.1% on OC000459 compared with 4.3% on placebo (not significant); PMID 21762224 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject TIMAPIPRANT Small molecule 200 mg Oral

Indications