drugset / Trial / NCT01047553

Study to Evaluate the Safety and Efficacy of Formoterol in a Daily Dose of 18 µg (9 µg Twice Daily) in Japanese Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT01047553 ↗

Phase 3 Completed 251 enrolled AstraZeneca
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a multicentre, open, randomised, parallel-group study with formoterol 9 μg one inhalation b.i.d, or standard COPD therapy. Standard (reference) COPD treatment arm should be the group to refer to when safety results of formoterol arm will be evaluated. 240 patients with moderate-to-severe COPD will be randomised (120 patients in the formoterol-arm and 120 patients on standard COPD therapy).

Timeline

Start
2009-12
Primary completion
2011-01
Completion
2011-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Formoterol Other / unclassified 9 ug Inhaled