Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BGF MDI 320/28.8/9.6 μg · 2 trials · 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. Treatment policy was implemented to handle all intercurrent events (ICEs) with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Rate of severe asthma exacerbations was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). An asthma exacerbation was severe if it resulted in at least 1 of the following: systemic corticosteroids for 3 days, an ER/urgent care visit requiring systemic corticosteroids, a hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Rate of severe asthma exacerbations was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). An asthma exacerbation was severe if it resulted in at least 1 of the following: a course of systemic corticosteroids for 3 days to treat symptoms of asthma worsening, an ER/urgent care visit that required treatment with systemic corticosteroids, an inpatient hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event of the highest severity. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
| Arm | Type | Description |
|---|---|---|
| Budesonide, glycopyrronium, and formoterol fumarate (BGF) MDI 320/28.8/9.6 μg | EXPERIMENTAL | BGF MDI 320/28.8/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI) |
| BGF MDI 320/14.4/9.6 μg | EXPERIMENTAL | BGF MDI 320/14.4/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI) |
| Budesonide and formoterol fumarate (BFF) MDI 320/9.6 μg | ACTIVE_COMPARATOR | BFF MDI 320/9.6 μg (Experimental/Comparator) Budesonide and formoterol fumarate (PT009) Metered Dose Inhaler (MDI) |
| Symbicort® | ACTIVE_COMPARATOR | Budesonide/ formoterol fumarate pressurized metered dose inhaler (pMDI) 320/9 μg |
| Name | Type | Description |
|---|---|---|
| BGF MDI 320/28.8/9.6 μg | DRUG | Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler |
| BGF MDI 320/14.4/9.6 μg | DRUG | Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler |
| BFF MDI 320/9.6 μg | DRUG | Budesonide and formoterol fumarate metered dose inhaler |
| BFF pMDI 320/9 μg | DRUG | Budesonide/formoterol fumarate pressurized metered dose inhaler |
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. Documented history of physician-diagnosed asthma \> and/or = 1 year prior to V1. 3. Regularly using a stable daily ICS/L...
BGF MDI 320/14.4/9.6 μg is an investigational fixed-dose combination metered dose inhaler being developed for the treatment of COPD (Chronic Obstructive Pulmonary Disease) and asthma. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
BGF MDI 320/14.4/9.6 μg is a combination inhaler containing budesonide, an inhaled corticosteroid; glycopyrronium, a long-acting muscarinic antagonist; and formoterol fumarate, a long-acting beta-agonist. This triple combination targets inflammation, bronchoconstriction, and airway mucus production in respiratory diseases.
BGF MDI 320/14.4/9.6 μg is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy in patients with asthma and COPD.
BGF MDI 320/14.4/9.6 μg is currently in Phase 3 clinical development. It is an investigational drug and has not received regulatory approval. The ongoing Phase 3 trial is evaluating its effects on cardiopulmonary outcomes in patients with COPD, while two earlier Phase 3 asthma trials have been completed.
BGF MDI 320/14.4/9.6 μg is being studied in three Phase 3 trials. The completed asthma trials are NCT04609878 (KALOS) and NCT04609904 (LOGOS), each enrolling over 2,000 participants. The active COPD trial is NCT06283966, which is recruiting 5,000 participants aged 40 years and older.
BGF MDI 320/14.4/9.6 μg is the same drug as PT010, as indicated by the clinical trial titles that reference PT010. The drug is a fixed-dose combination of budesonide, glycopyrronium, and formoterol fumarate delivered via a metered dose inhaler for the treatment of asthma and COPD.