At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 328 enrolled
Drug / intervention
Symbicort Turbuhaler (Budesonide/formoterol) +1 moredrug
Likely dose
Symbicort Turbuhaler (Budesonide/formoterol) 4.5 microgramfrom 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-label Phase III, Multi-centre 52-week , Parallel-group Study Evaluating the Safety and Efficacy of Symbicort Turbuhaler 320/9 Twice Daily Compared With Standard Treatment in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 3 clinical trial evaluating Symbicort Turbuhaler (Budesonide/formoterol) and Drug: any available COPD treatment; investigator to decide for Chronic Obstructive Pulmonary Disease. Completed, enrolled 328 participants across 17 sites.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of Symbicort Turbuhaler compared to standard COPD treatment during one year in Japanese patients with COPD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2010
First PostedFeb 2010
Primary CompletionOct 2011
TodayJul 2026
First PostedFeb 18, 2010
Enrollment StartJan 1, 2010
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.4 years ago
Interventions
Symbicort Turbuhaler (Budesonide/formoterol)drug
2 x 160/4.5 microgram, inhalation, bid, 52 weeks
Drug: any available COPD treatment; investigator to decidedrug
According to investigator decision, 52 weeks, Standard COPD treatment according to investigator decision