Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | PHASE3 | COMPLETED | 645 | — | — | Jan 12, 2022 | Feb 26, 2025 | Jan 28, 2026 | 142 | United States, Canada +5 |
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24. FEV1 AUC0-3 is calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time to report the result in liters. Treatment policy is implemented to handle all intercurrent events with the exception of initiation of new asthma therapy or administration of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of randomised study intervention, for which the composite strategy is implemented.
| Arm | Type | Description |
|---|---|---|
| BFF MDI 320/9.6 μg | EXPERIMENTAL | Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg |
| BFF MDI 160/9.6 μg | EXPERIMENTAL | Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg |
| BD MDI 320 μg | EXPERIMENTAL | Budesonide MDI (BD MDI), 320 μg |
| Open-label Symbicort TBH 320/9 μg | ACTIVE_COMPARATOR | Open-Label Comparator Symbicort Turbuhaler 320/9 μg |
| Name | Type | Description |
|---|---|---|
| BFF MDI 320/9.6 μg | DRUG | Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg |
| BFF MDI 160/9.6 μg | DRUG | Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg |
| BD MDI 320 μg | DRUG | Budesonide MDI (BD MDI), 320 μg |
| Open-label Symbicort TBH 320/9 μg | DRUG | Open-label Symbicort Turbuhaler 320/9 μg |
Inclusion Criteria: 1. 12 to 80 years of age, male and female, BMI \<40 kg/m2; females must be not of childbearing potential or using a form of highly effective birth control. 2. Participants who have a documented history of physician-diagnosed asthma ≥ 6 months prior to Visit 1, according to GINA ...