drugset / Trial / NCT00628862

Evaluation of Efficacy and Safety of Formoterol in Patients With COPD Compared With Placebo in Patients in Japan, EU

NCT00628862 ↗

Phase 3 Completed 613 enrolled AstraZeneca
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to show the efficacy and safety of formoterol for the maintenance treatment of patients with COPD compared with placebo in patients in Japan and in European countries during 12 weeks.

Timeline

Start
2007-12
Primary completion
2009-04
Completion
2009-04

Outcome

Met primary endpoint

paper End of study increases in FEV1 60-min post-dose were significantly greater (p < 0.001 for both) with formoterol 4.5 and 9 μg bid PMID 22085439 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Formoterol Other / unclassified 4.5 mg Inhaled
Subject Formoterol Other / unclassified 9 mg Inhaled