drugset / Trial / NCT05202262
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)
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2022-01-12
- Primary completion
- 2025-02-26
- Completion
- 2025-02-26
Outcome
Met primary endpoint
registry analysis (superiority test); BFF MDI 320/9.6 μg vs BD MDI 320 μg; p <0.0001; Mean Difference (Final Values) 0.173 (95% CI 0.112 to 0.233); ANCOVA NCT05202262 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Budesonide | Small molecule | 160 ug | Inhaled |
| Subject | Budesonide | Small molecule | 320 ug | Inhaled |
| Subject | Formoterol | Other / unclassified | 9 ug | Inhaled |
| Subject | Formoterol | Other / unclassified | 9.6 ug | Inhaled |