Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HFA MDI · 1 trial · 1 indication
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...
HFA MDI is an investigational small molecule metered-dose inhaler being developed for the treatment of asthma. It is designed to deliver medication via a hydrofluoroalkane propellant. The drug is currently in Phase 3 clinical development and has been studied in patients with well or partially controlled asthma.
HFA MDI is a small molecule delivered via a metered-dose inhaler. The specific molecular target is not disclosed in the available information. The drug is being studied for its potential to induce bronchospasm compared to a next-generation propellant in patients with asthma.
HFA MDI is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational inhaler for the treatment of asthma.
HFA MDI is currently in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. A Phase 3 clinical trial has been completed to assess bronchospasm potentially induced by the HFA propellant in an MDI in patients with asthma.
HFA MDI has one completed Phase 3 clinical trial registered under NCT05850494. The study assessed bronchospasm potentially induced by next-generation propellant versus HFA propellant in an MDI in participants with well or partially controlled asthma. The trial enrolled 52 participants in the United States and was randomized, double-blind, and active-controlled.
HFA MDI is not the same as a next-generation propellant MDI. The clinical trial NCT05850494 compared the bronchospasm potential of HFA MDI against a next-generation propellant MDI. HFA MDI uses a hydrofluoroalkane propellant, while the comparator uses a different, next-generation propellant technology.