At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 558 enrolled
Drug / intervention
Budesonide/formoterol (SYMBICORT) pMDI +1 moredrug
Likely dose
Budesonide/formoterol (SYMBICORT) pMDI 4.5 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 12-week, Randomised, Double Blind, Active-controlled, Multi-centre, Phase IIIB Study Comparing the Efficacy and Safety of SYMBICORT® pMDI 160/4.5 mg x 2 Actuations Twice Daily Versus Budesonide HFA pMDI 160 mg x 2 Actuations Twice Daily, in Adult/Adolescent (> 12 Yrs) Hispanic Subjects With Asthma
In Brief
A Phase 3 clinical trial evaluating Budesonide/formoterol (SYMBICORT) pMDI and Budesonide HFA pMDI for Asthma. Completed, enrolled 558 participants across 39 sites in 2 countries.
Detailed Summary
The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration(FDA)) in the Hispanic population.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2007
First PostedJan 2007
Primary CompletionJun 2008
TodayJul 2026
First PostedJan 9, 2007
Enrollment StartJan 1, 2007
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 19.5 years ago
Interventions
Budesonide/formoterol (SYMBICORT) pMDIdrug
SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
Budesonide HFA pMDIdrug
Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily