At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,026 enrolled
Drug / intervention
Symbicort +3 moredrug
Likely dose
Symbicort 4.5 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 Phase IIIB, 6-Month, Double-blind, Double-dummy, Randomized, Parallel-group, Multicenter Exacerbation Study of Symbicort® Pressurized Metered-Dose Inhaler (pMDI) 160/4.5 μg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler 4.5 μg x 2 Inhalations Twice-daily in Cronic Obstructive Pulmonary Disease (COPD) Patients.
In Brief
A Phase 3 clinical trial evaluating Symbicort, Formoterol turbohaler, and 2 other interventions for COPD Patients. Completed, enrolled 2,026 participants across 371 sites in 11 countries.
Detailed Summary
Comparing the efficacy of Symbicort® pMDI and Formoterol Turbuhaler in reducing exacerbations in patients with Chronic Obstructive Pulmonary Disease (COPD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD Patients
CountriesArgentina, Bulgaria, Chile, Czechia, Germany, Mexico, Poland, Puerto Rico, South Africa, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 2014
Enrollment StartJun 2014
Primary CompletionFeb 2016
TodayJul 2026
First PostedJun 6, 2014
Enrollment StartJun 27, 2014
Primary CompletionFeb 8, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.1 years ago
Interventions
Symbicortdrug
Budesonide/formoterol pMDI, 160/4.5 μg x 2 actuations BID, for oral inhalation, 120 doses
Formoterol turbohalerdrug
Formoterol Turbuhaler 4.5 μg x 2 actuations BID, for oral inhalation, 60 doses
Placebo for Symbicort pMDIother
pMDI, aerosol for oral inhalation, placebo, 120 doses
Placebo for Formoterol Turbohalerother
PLacebo powder for oral inhalation, 60 doses