At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 54 enrolled
Drug / intervention
80/2.25 μg Symbicort pMDI +4 moredrug
Likely dose
80/2.25 μg Symbicort pMDIfrom 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 2, Randomized, Blinded, 5-period Cross-over, Placebo and Active Controlled, Multicenter, Dose-finding Study Comparing Single Doses of Formoterol 2.25 µg, 4.5 µg, and 9 µg Delivered Via Symbicort pMDI and Foradil® 12 µg Evaluating the Relative Bronchodilating Effects and Safety in Children
In Brief
A Phase 2 clinical trial evaluating 80/2.25 μg Symbicort pMDI, 80/4.5 μg Symbicort pMDI, and 3 other interventions for Asthma. Completed, enrolled 54 participants across 34 sites in 6 countries.
Detailed Summary
This purpose of the study is to investigate the bronchodilating effects of 3 different dosages of formoterol given in combination with budesonide as Symbicort pMDI.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesBulgaria, Czechia, Hungary, Poland, South Africa, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2010
Enrollment StartSep 2010
Primary CompletionDec 2011
TodayJul 2026
First PostedJun 3, 2010
Enrollment StartSep 1, 2010
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.1 years ago
Interventions
80/2.25 μg Symbicort pMDIdrug
inhalation
80/4.5 μg Symbicort pMDIdrug
inhalation
Foradil Aerolizer 12 μgdrug
inhalation
40 μg budesonide HFA pMDIdrug
inhalation
placebo HFA pMDIdrug
inhalation