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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05850494 | Study to Assess Bronchospasm Potentially Induced by Next-Generation Propellant vs HFA Propellant in an MDI in Participants With Well/Partially Controlled Asthma | PHASE3 | COMPLETED | 52 | — | — | May 2, 2023 | Aug 21, 2023 | Feb 6, 2026 | 4 | United States |
The change from baseline (30 minutes pre-dose) in normalized FEV1 AUC0-15 min postdose induced by Treatment HFO was compared with Treatment HFA.
| Arm | Type | Description |
|---|---|---|
| Treatment A: HFO propellant only MDI | EXPERIMENTAL | Test arm, 4 inhalations per dose |
| Treatment B: HFA propellant only MDI | ACTIVE_COMPARATOR | Reference arm, 4 inhalations per dose |
| Name | Type | Description |
|---|---|---|
| HFA MDI | DRUG | * Dose formulation: MDI * Unit dose strength(s): Reference (propellant only) * Dosage Level: 4 inhalations, single dose * Route of administration: Oral inhalation * Participants will receive treatment A in 1 or 2 possible sequences AB or BA |
| HFO MDI | DRUG | * Dose formulation: MDI * Unit dose strength(s): Experimental (propellant only) * Dosage Level: 4 inhalations, single dose * Route of administration: Oral inhalation * Participants will receive treatment A in 1 or 2 possible sequences AB or BA |
Inclusion Criteria: * Age 1. Male and female participant must be 18 to 45 years of age inclusive, at the time of signing the informed consent form (ICF). Type of Participant and Disease Characteristics 2. Participants who have a documented history of physician-diagnosed asthma ≥ 12...