At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,762 enrolled
Drug / intervention
Budesonide/Formoterol fumarate dihydrate +2 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.
Randomized, Single Blind, Parallel Group, Placebo Controlled, Multidose Study Comparing the Therapeutic Equivalence of a 3M Budesonide/Formoterol Fumarate Inhaler and a Symbicort® Reference Inhaler in Adult Subjects With Asthma
In Brief
A Phase 3 clinical trial evaluating Budesonide/Formoterol fumarate dihydrate, Symbicort, and 1 other intervention for Asthma. Completed, enrolled 1,762 participants across 95 sites.
Detailed Summary
A randomized multiple-dose, placebo-controlled, parallel group design consisting of a 2-week run-in period followed by a 6-week treatment period of the placebo, Test product (Budesonide 80 mcg / Formoterol fumarate dihydrate 4.5 mcg), or Reference product Symbicort® inhalation aerosol.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartDec 2016
First PostedJan 2017
Primary CompletionFeb 2018
TodayJul 2026
First PostedJan 10, 2017
Enrollment StartDec 29, 2016
Primary CompletionFeb 8, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.5 years ago
Interventions
Budesonide/Formoterol fumarate dihydratedrug
Experimental: Treatment 1
Symbicortdrug
Active Comparator: Treatment 2
Placebodrug
Placebo Comparator: Treatment 3