At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 882 enrolled
Drug / intervention
Symbicort pMDI +2 moredrug
Likely dose
Symbicort pMDI 2.25 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 3, 12-Week, Double-Blind, Randomized, Parallel-Group, Multicenter Study Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg, 2 Actuations Twice Daily, and Symbicort pMDI 80/4.5 μg, 2 Actuations Twice Daily, Compared With Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to <12 Years With Asthma
In Brief
A Phase 3 clinical trial evaluating Symbicort pMDI and Budesonide pMDI for Asthma. Completed, enrolled 882 participants across 70 sites in 4 countries.
Detailed Summary
The purpose is to investigate the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to \<12 Years with Asthma during 12 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesMexico, Panama, Slovakia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 2014
Enrollment StartApr 2014
Primary CompletionApr 2016
TodayJul 2026
First PostedMar 19, 2014
Enrollment StartApr 1, 2014
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 12.3 years ago
Interventions
Symbicort pMDIdrug
Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily
Symbicort pMDIdrug
Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily
Budesonide pMDIother
Budesonide pMDI 80µg, 2 acuations twice daily