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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05755932 | Study to Assess Effect of Next-Generation Propellant MDI on Mucociliary Clearance Vs. HFA Propellant MDI in Healthy Participants | PHASE3 | COMPLETED | 35 | — | — | Jun 14, 2023 | Jul 22, 2024 | Feb 25, 2026 | 5 | United States, United Kingdom |
Change from baseline in MCC through 60 minutes, following inhalation of 99m technetium-labelled colloid (sulfur or albumin) and gamma camera imaging
| Arm | Type | Description |
|---|---|---|
| Treatment A: HFO MDI | EXPERIMENTAL | Test arm, 6 inhalations BID for 7 days |
| Treatment B: HFA MDI | ACTIVE_COMPARATOR | Reference arm, 6 inhalations BID for 7 days |
| Name | Type | Description |
|---|---|---|
| HFO-1234ze(E) | DRUG | * Dose formulation: metered dose inhaler (MDI) * Unit dose strength(s): Experimental (propellant only) * Dosage level(s): 6 inhalations, BID * Route of administration: Oral inhalation * Participants will receive treatment A in 1 of 2 possible treatment sequences: AB or BA |
| HFA-134a | DRUG | * Dose formulation: metered dose inhaler (MDI) * Unit dose strength(s): Reference (propellant only) * Dosage level(s): 6 inhalations, BID * Route of administration: Oral inhalation * Participants will receive treatment B in 1 of 2 possible treatment sequences: AB or BA. |
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Capable of giving signed informed consent as described in the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF...