At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 613 enrolled
Drug / intervention
Formoterol Turbuhaler® 4.5mg +2 moredrug
Likely dose
Formoterol Turbuhaler® 4.5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 12-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-national, Phase III, Efficacy and Safety Study of Inhaled Formoterol 4.5 μg and 9 μg Twice Daily in Japanese and European Patients With Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 3 clinical trial evaluating Formoterol Turbuhaler® 4.5mg, Formoterol Turbuhaler® 9 mg, and 1 other intervention for Chronic Obstructive Pulmonary Disease. Completed, enrolled 613 participants across 47 sites in 5 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesBulgaria, Japan, Romania, Russia, Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2007
First PostedMar 2008
Primary CompletionApr 2009
TodayJul 2026
First PostedMar 5, 2008
Enrollment StartDec 1, 2007
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.3 years ago
Interventions
Formoterol Turbuhaler® 4.5mgdrug
4.5 mg inhaled twice daily
Formoterol Turbuhaler® 9 mgdrug
9 mg inhaled twice daily
Turbuhaler® placebodrug
placebo inhaled twice daily