At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 251 enrolled
Drug / intervention
Formoterol (OT)drug
Likely dose
Formoterol (OT) 9 μgfrom 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.
An Open Phase III, Multi-centre 52-week, Parallel-group Study Evaluating the Safety and Efficacy of Formoterol 18 μg Daily Dose Compared With Standard COPD Treatment, in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 3 clinical trial evaluating Formoterol (OT) for Chronic Obstructive Pulmonary Disease. Completed, enrolled 251 participants across 27 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2009
First PostedJan 2010
Primary CompletionJan 2011
Study CompletionJul 2011
TodayJul 2026
First PostedJan 13, 2010
Enrollment StartDec 1, 2009
Primary CompletionJan 1, 2011
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 16.5 years ago
Interventions
Formoterol (OT)drug
9 μg/dose, Inhaled, twice daily for 52 weeks