Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Bretzri
Breztri · 3 trials · 2 indications
Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on cardiopulmonary outcomes.
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 |
|---|---|---|
| BGF arm | EXPERIMENTAL | BGF MDI 320/14.4/9.6 μg BID |
| GFF arm | EXPERIMENTAL | GFF MDI 14.4/9.6 μg BID |
| 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 320/14.4/9.6 μg | DRUG | Budesonide, glycopyrronium, and formoterol fumarate pressurized inhalation suspension |
| GFF MDI 14.4/9.6 μg | DRUG | Glycopyrronium and formoterol fumarate pressurized inhalation suspension |
| BGF MDI 320/28.8/9.6 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. Male or female participants must be 40 to 80 years of age inclusive, at the time of signing the ICF. 2. Demonstrate acceptable MDI administration technique at Visit 1 (V1) and Visit 2 (V2) 3. A diagnosis of COPD confirmed by a post-bronchodilator FEV1/FVC ratio \< 70% ...