At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 186 enrolled
Drug / intervention
Indacaterol 300 µg +1 moredrug
Likely dose
Indacaterol 300 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.
A 52-week Treatment, Multi-center, Randomized, Open Label, Parallel Group Study to Assess the Long Term Safety and Efficacy of Indacaterol (300 µg o.d.) Using Salmeterol (50 µg b.i.d.) as an Active Control in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 3 clinical trial evaluating Indacaterol 300 µg and Salmeterol 50 µg for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 186 participants across 37 sites.
Detailed Summary
This study is designed to collect long term safety data of indacaterol (300 µg o.d.) in Japanese patients with moderate to severe COPD. Data from this study will be used for the registration of indacaterol in Japan.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2009
First PostedApr 2009
Primary CompletionOct 2010
TodayJul 2026
First PostedApr 7, 2009
Enrollment StartMar 1, 2009
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 17.2 years ago
Interventions
Indacaterol 300 µgdrug
Indacaterol 300 µg once daily (od) via SDDPI
Salmeterol 50 µgdrug
Salmeterol 50 µg twice daily (bid) via Diskus®