At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 304 enrolled
Drug / intervention
budesonide +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.
Phase 2, Double-blind, Randomized, Parallel-group, Placebo-controlled, Multicenter Study, Comparing Budesonide pMDI 160 ug Bid With Placebo: a 6-week Efficacy and Safety Study in Children Aged 6 to <12 Years With Asthma
In Brief
A Phase 2 clinical trial evaluating budesonide and placebo for Asthma. Completed, enrolled 304 participants across 87 sites in 7 countries.
Detailed Summary
This purpose of the study is to investigate if budesonide pMDI 160 �g twice a day during 6 weeks is effective and safe in treating asthmatic children aged 6 to \<12 years
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesBulgaria, Hungary, Latvia, Poland, Slovakia, South Africa, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2010
Enrollment StartJul 2010
Primary CompletionApr 2013
TodayJul 2026
First PostedJun 3, 2010
Enrollment StartJul 1, 2010
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 16.1 years ago
Interventions
budesonidedrug
pMDI, inhalation, bid, 6 weeks
placebodrug
pMDI, inhalation, bid, 6 weeks