At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 742 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 52-week, Randomised, Double-blind, Parallel-group, Multi-centre, Phase IIIB Study Comparing the Long Term Safety of SYMBICORT® pMDI 160/4.5 mg x 2 Actuations Twice Daily to Budesonide HFA pMDI 160 mg x 2 Actuations Twice Daily in Adult/Adolescent (≥12 Years) African American Subjects With Asthma
In Brief
A Phase 3 clinical trial evaluating Budesonide/formoterol (SYMBICORT) pMDI and Budesonide HFA pMDI for Asthma. Completed, enrolled 742 participants across 122 sites.
Detailed Summary
The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration, FDA) in the African American population.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 2007
Enrollment StartFeb 2007
Primary CompletionNov 2009
TodayJul 2026
First PostedJan 9, 2007
Enrollment StartFeb 1, 2007
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 19.5 years ago
Interventions
Budesonide/formoterol (SYMBICORT) pMDIdrug
Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID)
Budesonide HFA pMDIdrug
Budesonide HFA pMDI 160 ug x 2 actuations BID