At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 160 enrolled
Drug / intervention
QVA149 +1 moredrug
Likely dose
QVA149 110 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 Tolerability of QVA149 (110 Mcg Indacaterol / 50 Mcg Glycopyrrolate o.d.) Using Tiotropium (18 Mcg o.d.) as an Active Control in Japanese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 3 clinical trial evaluating QVA149 and Tiotropium for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 160 participants across 35 sites.
Detailed Summary
This is a 52-week treatment, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily QVA149 (indacaterol and NVA237 (\[glycopyrronium bromide\]) using tiotropium as an active control in Japanese patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2011
First PostedJan 2011
Primary CompletionSep 2012
TodayJul 2026
First PostedJan 28, 2011
Enrollment StartJan 1, 2011
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 15.4 years ago
Interventions
QVA149drug
QVA149 (110 μg indacaterol / 50 μg glycopyrronium o.d.), delivered via Concept1
Tiotropiumdrug
Tiotropium (18 μg o.d.), delivered via Handihaler®