At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,200 enrolled
Drug / intervention
Budesonide/formoterol (SYMBICORT) pMDI +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 Phase IIIB, 12-Month, Double-blind, Double-dummy,Randomised, Parallel-group, Multicentre Exacerbation Study of SYMBICORT® pMDI 160/4.5 μg x 2 Actuations Twice-daily and 80/4.5 μg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler® 4.5 μg x 2 Inhalations Twice-daily in COPD Subjects
In Brief
A Phase 3 clinical trial evaluating Budesonide/formoterol (SYMBICORT) pMDI and Formoterol Turbuhaler for Chronic Obstructive Pulmonary Disease. Completed, enrolled 1,200 participants across 140 sites in 9 countries.
Detailed Summary
The purpose of this study is to determine if SYMBICORT® delivered via a pressurized metered-dose inhaler, referred to as a pMDI, is effective in preventing COPD exacerbations.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesArgentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, United States, Venezuela
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2007
First PostedJan 2007
Primary CompletionAug 2009
TodayJul 2026
First PostedJan 9, 2007
Enrollment StartJan 1, 2007
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 19.5 years ago
Interventions
Budesonide/formoterol (SYMBICORT) pMDIdrug
Formoterol Turbuhalerdrug