At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 645 enrolled
Drug / intervention
BFF MDI 320/9.6 μg +3 moredrug
Likely dose
BFF MDI 320/9.6 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 Randomized, Double-Blind, Parallel Group, Multicenter 24 Week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler and Open-Label Symbicort® Turbuhaler® in Participants With Inadequately Controlled Asthma (VATHOS).
In Brief
A Phase 3 clinical trial evaluating BFF MDI 320/9.6 μg, BFF MDI 160/9.6 μg, and 2 other interventions for Asthma. Completed, enrolled 645 participants across 142 sites in 7 countries.
Detailed Summary
This is a 24 week study to evaluate the efficacy and safety of budesonide and formoterol fumarate metered dose inhaler in adults and adolescents with inadequately controlled asthma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesCanada, Germany, Italy, Japan, Spain, United States, Vietnam
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
Enrollment StartJan 2022
First PostedJan 2022
Primary CompletionFeb 2025
TodayJul 2026
First PostedJan 21, 2022
Enrollment StartJan 12, 2022
Primary CompletionFeb 26, 2025
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 4.4 years ago
Interventions
BFF MDI 320/9.6 μgdrug
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg
BFF MDI 160/9.6 μgdrug
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg
BD MDI 320 μgdrug
Budesonide MDI (BD MDI), 320 μg
Open-label Symbicort TBH 320/9 μgdrug
Open-label Symbicort Turbuhaler 320/9 μg