Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BFF MDI 320/9.6 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 24. 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 320/9.6 μg | EXPERIMENTAL | Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg |
| BFF MDI 160/9.6 μg | EXPERIMENTAL | Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg |
| BD MDI 320 μg | EXPERIMENTAL | Budesonide MDI (BD MDI), 320 μg |
| Open-label Symbicort TBH 320/9 μg | ACTIVE_COMPARATOR | Open-Label Comparator Symbicort Turbuhaler 320/9 μg |
| Name | Type | Description |
|---|---|---|
| BFF MDI 320/9.6 μg | DRUG | Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg |
| BFF MDI 160/9.6 μg | DRUG | Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg |
| BD MDI 320 μg | DRUG | Budesonide MDI (BD MDI), 320 μg |
| Open-label Symbicort TBH 320/9 μg | DRUG | Open-label Symbicort Turbuhaler 320/9 μg |
Inclusion Criteria: 1. 12 to 80 years of age, male and female, BMI \<40 kg/m2; females must be not of childbearing potential or using a form of highly effective birth control. 2. Participants who have a documented history of physician-diagnosed asthma ≥ 6 months prior to Visit 1, according to GINA ...
BFF MDI 320/9.6 μg is an investigational small molecule being developed for the treatment of asthma. It is a metered dose inhaler containing budesonide and formoterol fumarate, intended for use in adult and adolescent patients with inadequately controlled asthma. The drug is currently in Phase 3 clinical development.
BFF MDI 320/9.6 μg is a combination inhaler containing budesonide, a corticosteroid, and formoterol fumarate, a long-acting beta-agonist. These components work together to reduce airway inflammation and relax bronchial muscles, helping to control asthma symptoms. The drug is administered via a metered dose inhaler.
BFF MDI 320/9.6 μg is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with asthma.
BFF MDI 320/9.6 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 VATHOS, has been completed, and the drug is being evaluated for the treatment of asthma in adult and adolescent patients.
BFF MDI 320/9.6 μg has been studied in one Phase 3 clinical trial with the identifier NCT05202262. This 24-week study, titled VATHOS, assessed the efficacy and safety of the drug in adult and adolescent participants with inadequately controlled asthma. The trial enrolled 645 participants and has been completed.
BFF MDI 320/9.6 μg is a fixed-dose combination of budesonide and formoterol fumarate delivered via a metered dose inhaler. The drug name reflects the specific dosage of each component, with 320 μg of budesonide and 9.6 μg of formoterol fumarate per inhalation.