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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06502366 | A Study to Investigate the Effect on Lung Function of BDA Formulated With a Next Generation Propellant Compared With an Approved Asthma Treatment (BDA With HFA Propellant) in Participants With Asthma | PHASE3 | ACTIVE NOT_RECRUITING | 422 | — | — | Jul 22, 2024 | Mar 3, 2026 | Feb 13, 2026 | 128 | United States, China +4 |
To assess the equivalence of BDA MDI HFO relative to BDA MDI HFA on lung function in participants with asthma.
| Arm | Type | Description |
|---|---|---|
| BDA MDI HFO | ACTIVE_COMPARATOR | 160/180 µg Budesonide/albuterol pressurized inhalation suspension, HFO |
| BDA MDI HFA | ACTIVE_COMPARATOR | 160/180 µg Budesonide/albuterol pressurized inhalation suspension, HFA |
| Placebo MDI HFA | PLACEBO_COMPARATOR | Placebo pressurized inhalation suspension, HFA |
| Name | Type | Description |
|---|---|---|
| BDA MDI HFO 160/180 μg | DRUG | Budesonide/albuterol pressurized inhalation suspension, HFO |
| BDA MDI HFA 160/180 μg | DRUG | Budesonide/albuterol pressurized inhalation suspension, HFA |
| Placebo MDI HFA | DRUG | Placebo pressurized inhalation suspension, HFA |
Inclusion Criteria: * Participant must be ≥ 18 years of age at the time of signing the ICF. * Participants who have physician diagnosed asthma as defined by GINA for at least 12 months prior to Visit 1. * Eligible participants are on either a) no daily inhaled maintenance therapy or b) daily inhale...