At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 660 enrolled
Drug / intervention
Symbicort (budesonide/formoterol turbuhaler 320/9ug) +1 moredrug
Likely dose
Not stated in 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, Double-blind, Randomised, Parallel Group, Multi-centre, Study to Evaluate Efficacy and Safety of Budesonide/Formoterol (Symbicort Turbuhaler®) 320/9 µg One Inhalation Twice Daily on Top of Tiotropium (Spiriva®) 18 µg One Inhalation Once Daily
In Brief
A Phase 4 clinical trial evaluating Symbicort (budesonide/formoterol turbuhaler 320/9ug) and Spiriva (tiotropium bromide 18ug) for Chronic Obstructive Pulmonary Disease, COPD. Completed, enrolled 660 participants across 93 sites in 9 countries.
Detailed Summary
The purpose of this study is to investigate the effect of combined treatment with Symbicort and Spiriva, in terms of improvement of lung function, symptoms and inflammatory markers, in patients with severe COPD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, France, Germany, Hungary, Poland, Slovakia, Spain, Sweden
Collaborators--
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2007
First PostedJul 2007
Primary CompletionJun 2008
TodayJul 2026
First PostedJul 4, 2007
Enrollment StartMay 1, 2007
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 19.0 years ago
Interventions
Symbicort (budesonide/formoterol turbuhaler 320/9ug)drug
Symbicort (budesonide/formoterol turbuhaler 320/9ug)
Spiriva (tiotropium bromide 18ug)drug
Spiriva (tiotropium bromide 18ug)