At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 311 enrolled
Drug / intervention
Budesonide / formoterol fumarate (SYMBICORT) +1 moredrug
Likely dose
Budesonide / formoterol fumarate (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 12-wk, Rand., Double-blind, Double Dummy, Multi-ctr., Phase IV Study Comparing Efficacy and Safety of SYMBICORT® pMDI 160/4.5 ug x 2 Actuations Twice Daily Versus Pulmicort® (Budesonide Inhalation Powder DPI) 180 ug x 2 Inhalations Twice Daily, in Adult and Adolescent African American Subjects With Asthma
In Brief
A Phase 4 clinical trial evaluating Budesonide / formoterol fumarate (SYMBICORT) and Budesonide for Asthma. Completed, enrolled 311 participants across 57 sites.
Detailed Summary
To compare the efficacy of SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily (bid) to that of budesonide inhalation powder DPI 180 μg x 2 inhalations bid, in African American(self-reported) subjects with inhaled corticosteroid (ICS) dependent asthma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2008
First PostedJun 2008
Primary CompletionSep 2009
TodayJul 2026
First PostedJun 20, 2008
Enrollment StartJun 1, 2008
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.0 years ago
Interventions
Budesonide / formoterol fumarate (SYMBICORT)drug
160/4.5 μg x 2 actuations twice daily (bid)
Budesonidedrug
inhalation powder 180 μg x 2 inhalations bid (PULMICORT)