At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 107 enrolled
Drug / intervention
Budesonide/formoterol pMDI 40/2.25ug + spacer +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 4-week, Open-label, Randomized, Multi-centre, Parallel-group Study Evaluating the Safety and Efficacy of 4 Actuations Symbicort® (Budesonide/Formoterol) HFA pMDI 40/2.25 μg Twice Daily, With and Without Spacer, in Children (6-11 Years) With Asthma
In Brief
A Phase 3 clinical trial evaluating Budesonide/formoterol pMDI 40/2.25ug + spacer and Budesonide/formoterol pMDI 40/2.25 ug for Asthma. Completed, enrolled 107 participants across 11 sites in 3 countries.
Detailed Summary
The purpose of the study is to compare Symbicort pMDI with and without spacer in terms of steroid potency, improvement of lung function and asthma symptoms in children with asthma (6-11 years).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesHungary, Poland, Russia
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2007
First PostedSep 2007
Primary CompletionFeb 2008
TodayJul 2026
First PostedSep 28, 2007
Enrollment StartSep 1, 2007
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 18.8 years ago
Interventions
Budesonide/formoterol pMDI 40/2.25ug + spacerdrug
Budesonide/formoterol pMDI 40/2.25 ugdrug