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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05755906 | A 12-week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler in Participants With Inadequately Controlled Asthma (LITHOS) | PHASE3 | COMPLETED | 374 | — | — | Feb 27, 2023 | Nov 19, 2024 | Jan 28, 2026 | 104 | 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 12. 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 160/9.6 μg BID (320/19.2μg/day) | EXPERIMENTAL | Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), BDI (320/19.2μg/day) |
| BD MDI 160 μg BID (320 μg/day) | ACTIVE_COMPARATOR | Budesonide (BD) metered-dose inhaler (MDI), 160 μg BID (320 μg/day) |
| Name | Type | Description |
|---|---|---|
| BFF MDI 160/9.6 μg BID (320/19.2μg/day) | DRUG | Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg BID (320/19.2μg/day) |
| BD MDI 160 μg BID (320 μg/day) | DRUG | Budesonide (BD) metered-dose inhaler (MDI), 160 μg BID (320 μg/day) |
Inclusion Criteria 1. 12 to 80 years of age, male and female, BMI \<40 kg/m2; females of childbearing potential should be using highly effective birth control. 2. Participants who have a documented history of physician-diagnosed asthma ≥ 6 months prior to Visit 1, according to GINA guidelines \[GIN...