A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler in Adult and Adolescent Participants With Inadequately Controlled Asthma (VATHOS)
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Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
645actual
Sites
142
Countries
Canada, Germany, Italy +4
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-01-12 | actual | When the study began enrolling |
| Primary completion | 2025-02-26 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-02-26 | actual | The whole study's end, after follow-up |
| First posted | 2022-01-21 | actual | When this record first appeared on the registry |
| Results posted | 2026-01-28 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-01-28 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Asthma
Interventions
- Drug: BFF MDI 320/9.6 μg — also filed as BFF
- Drug: BFF MDI 160/9.6 μg — also filed as BFF
- Drug: BD MDI 320 μg — also filed as BD
- Drug: Open-label Symbicort TBH 320/9 μg — also filed as Symbicort TBH
Primary outcome
what the primary-completion date above is the date OFChange From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve 0 to 3 Hours (AUC0-3) at Week 24
measured At Week 24
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-11-07 · 6.8 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-11-27 · 11.8 MB · SAP_001.pdf
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