Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BFF MDI 160/9.6 μg · 1 trial · 1 indication
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 12. FEV1 AUC0-3 is calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time to report the result in liters. Treatment policy is implemented to handle all intercurrent events with the exception of initiation of new asthma therapy or administration of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of randomised study intervention, for which the composite strategy is implemented.
| Arm | Type | Description |
|---|---|---|
| BFF MDI 160/9.6 μg BID (320/19.2μg/day) | EXPERIMENTAL | Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), BDI (320/19.2μg/day) |
| BD MDI 160 μg BID (320 μg/day) | ACTIVE_COMPARATOR | Budesonide (BD) metered-dose inhaler (MDI), 160 μg BID (320 μg/day) |
| Name | Type | Description |
|---|---|---|
| BFF MDI 160/9.6 μg BID (320/19.2μg/day) | DRUG | Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg BID (320/19.2μg/day) |
| BD MDI 160 μg BID (320 μg/day) | DRUG | Budesonide (BD) metered-dose inhaler (MDI), 160 μg BID (320 μg/day) |
Inclusion Criteria 1. 12 to 80 years of age, male and female, BMI \<40 kg/m2; females of childbearing potential should be using highly effective birth control. 2. Participants who have a documented history of physician-diagnosed asthma ≥ 6 months prior to Visit 1, according to GINA guidelines \[GIN...
BFF MDI 160/9.6 μg is an investigational small molecule being developed for the treatment of asthma. It is a metered dose inhaler formulation containing budesonide and formoterol fumarate, intended for use in patients with inadequately controlled asthma. The drug is currently in Phase 3 clinical development.
BFF MDI 160/9.6 μg is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical trials to evaluate the efficacy and safety of this investigational asthma treatment.
BFF MDI 160/9.6 μg is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial, known as LITHOS, has been completed, evaluating the drug in patients with inadequately controlled asthma.
BFF MDI 160/9.6 μg is associated with one completed Phase 3 clinical trial, NCT05755906, titled LITHOS. This 12-week study assessed the efficacy and safety of budesonide and formoterol fumarate metered dose inhaler relative to budesonide metered dose inhaler in participants with inadequately controlled asthma. The trial enrolled 374 participants across multiple countries.
BFF MDI 160/9.6 μg is a metered dose inhaler formulation that contains budesonide and formoterol fumarate. The drug name reflects the combination of these two active ingredients, with 160 μg of budesonide and 9.6 μg of formoterol fumarate per dose. It is being studied as a fixed-dose combination for asthma.