Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BFF · 1 trial · 1 indication
Peak change from baseline in FEV1 within 4 hours post-dose was defined as the maximum of the FEV1 assessments within 4 hours post-dosing at each visit minus baseline, provided that there were at least 2 non-missing values during the first 4 hours post dose.
| Arm | Type | Description |
|---|---|---|
| Budesonide and formoterol fumarate (MDI BFF) | EXPERIMENTAL | Subject treated with MDI BFF followed by washout period |
| Symbicort Turbuhaler | ACTIVE_COMPARATOR | Subject treated with Symbicort followed by washout period |
| Name | Type | Description |
|---|---|---|
| BFF | COMBINATION_PRODUCT | Treatment with budesonide and formoterol furmate MDI (metered-dose inhaler) |
| Symbicort Turbuhaler | COMBINATION_PRODUCT | Treatment with budesonide and formoterol furmate DPI (dry-powder inhaler) |
Key Inclusion Criteria: 1. Subject must be 40 to 80 years of age inclusive, at the time of signing the ICF. 2. Individuals who have a physician diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) 3. Require COPD maintenance therapy: all subjects mu...
BFF is an investigational small molecule being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is a dual combination product containing budesonide and formoterol, delivered via an inhaler. BFF is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
BFF is a combination of two active ingredients: budesonide, a corticosteroid, and formoterol, a long-acting beta-agonist. These components work together to reduce inflammation and relax airway muscles, helping to improve breathing in patients with COPD. The specific molecular targets are the glucocorticoid receptor for budesonide and the beta-2 adrenergic receptor for formoterol.
BFF is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca is conducting clinical trials to evaluate the safety and efficacy of BFF in patients with Chronic Obstructive Pulmonary Disease (COPD).
BFF is currently in Phase 3 clinical development for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is an investigational drug, meaning it has not yet received regulatory approval and is still undergoing clinical trials to assess its safety and effectiveness.
BFF has one completed Phase 3 clinical trial registered under NCT04078126. This study compared the dual combination of budesonide and formoterol delivered via two different inhalers to determine which one results in the best effect on breathing. The trial enrolled 35 participants with COPD in Germany and was active-controlled.
Yes, BFF is a dual combination product containing budesonide and formoterol, two active pharmaceutical ingredients commonly used together for respiratory conditions. The drug is administered via an inhaler and is being studied specifically for the treatment of Chronic Obstructive Pulmonary Disease (COPD).