At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 485 enrolled
Drug / intervention
Budesonide and formoterol fumarate dehydrate (BF) SPIROMAX +1 moredrug
Likely dose
Budesonide and formoterol fumarate dehydrate (BF) SPIROMAX 9 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, Randomized, Open-Label, Parallel-Group Study to Evaluate the Mastery of Inhaler Technique for Budesonide Formoterol (BF) SPIROMAX® (160/4.5 and 320/9 mcg) as Compared With SYMBICORT® TURBOHALER® (200/6 and 400/12 mcg) as Treatment for Adult Patients With Asthma (The Easy Low Instruction Over Time [ELIOT] Study)
Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Feb 13, 2014·Updated Mar 22, 2024
In Brief
A Phase 3 clinical trial evaluating Budesonide and formoterol fumarate dehydrate (BF) SPIROMAX and SYMBICORT TURBOHALER budesonide and formoterol fumarate for Asthma. Completed, enrolled 485 participants across 74 sites.
Detailed Summary
This study is conducted to assess whether training participants on proper use of BF SPIROMAX and Symbicort TURBOHALER will improve their device-handling technique and potentially improve their treatment outcome, that is, better asthma control.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 2014
Enrollment StartMay 2014
Primary CompletionMar 2015
TodayJul 2026
First PostedFeb 13, 2014
Enrollment StartMay 28, 2014
Primary CompletionMar 13, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 12.4 years ago
Interventions
Budesonide and formoterol fumarate dehydrate (BF) SPIROMAXdrug
SPIROMAX (BF) Budesonide and formoterol fumarate dehydrate (160/4.5 and 320/9 μg)
SYMBICORT TURBOHALER budesonide and formoterol fumaratedrug
SYMBICORT® TURBOHALER® (200/6 and 400/12 μg)