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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04609904 | Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (LOGOS) | PHASE3 | COMPLETED | 2,187 | — | — | Mar 1, 2021 | Mar 20, 2025 | Apr 20, 2025 | 317 | United States, Brazil +14 |
| NCT04609878 | Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS) | PHASE3 | COMPLETED | 2,274 | — | — | Dec 15, 2020 | Mar 21, 2025 | Apr 20, 2025 | 360 | United States, Argentina +19 |
Primary end point(s) of Pooled Studies D5982C00007 and D5982C00008: Rate of severe asthma exacerbations
| Arm | Type | Description |
|---|---|---|
| Budesonide, glycopyrronium, and formoterol fumarate (BGF) MDI 320/28.8/9.6 μg | EXPERIMENTAL | BGF MDI 320/28.8/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI) |
| BGF MDI 320/14.4/9.6 μg | EXPERIMENTAL | BGF MDI 320/14.4/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI) |
| Budesonide and formoterol fumarate (BFF) MDI 320/9.6 μg | ACTIVE_COMPARATOR | BFF MDI 320/9.6 μg (Experimental/Comparator) Budesonide and formoterol fumarate (PT009) Metered Dose Inhaler (MDI) |
| Symbicort® | ACTIVE_COMPARATOR | Budesonide/ formoterol fumarate pressurized metered dose inhaler (pMDI) 320/9 μg |
| Name | Type | Description |
|---|---|---|
| BGF MDI 320/28.8/9.6 μg | DRUG | Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler |
| BGF MDI 320/14.4/9.6 μg | DRUG | Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler |
| BFF MDI 320/9.6 μg | DRUG | Budesonide and formoterol fumarate metered dose inhaler |
| BFF pMDI 320/9 μg | DRUG | Budesonide/formoterol fumarate pressurized metered dose inhaler |
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. Documented history of physician-diagnosed asthma \> and/or = 1 year prior to V1. 3. Regularly using a stable daily ICS/L...