At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 214 enrolled
Drug / intervention
Symbicort +2 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, Randomized, Multi-centre, Parallel-group Study Evaluating the Efficacy Safety, and Patient Use (User Study) of Symbicort® (Budesonide/Formoterol) Breath Actuated Metered Dose Inhaler (BA MDI) 2x160/4.5 μg Twice Daily Compared With Symbicort (Budesonide/Formoterol) AC (Actuation Counter) pMDI® 2x160/4.5 μg Twice Daily and Budesonide AC pMDI 2x160 μg Twice Daily in Adult and Adolescent Asthmatics
In Brief
A Phase 3 clinical trial evaluating Symbicort and Budesonide for Asthma. Completed, enrolled 214 participants across 41 sites in 4 countries.
Detailed Summary
This is a comparison of the efficacy of the Symbicort breath actuated dose inhaler to the Symbicort pressured meter dose inhaler after 12 weeks of a twice a day dose.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesBulgaria, Hungary, Russia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2011
Enrollment StartNov 2011
Primary CompletionAug 2012
TodayJul 2026
First PostedMay 25, 2011
Enrollment StartNov 1, 2011
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 15.1 years ago
Interventions
Symbicortdrug
Breath actuated metered dose inhaler
Symbicortdrug
Actuation counter pressured metered dose inhaler
Budesonidedrug
Actuation counter pressured metered dose inhaler