Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Delivered by MDI HFO (HFO-1234ze), BGF MDI HFO
BGF MDI HFO 320/14.4/9.6 μg · 2 trials · 2 indications
To assess the equivalence of BGF MDI HFO relative to BGF MDI HFA on lung function in participants with COPD
To assess the equivalence of BGF MDI HFO relative to BGF MDI HFA on lung function in participants with COPD
To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD
To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD
To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD. Adverse events of special interest in this study are respiratory events such as dysphonia, cough, dyspnea, wheezing, paradoxical bronchospasm, bronchospasm, and COPD exacerbations.
| Arm | Type | Description |
|---|---|---|
| Treatment Sequence 1 | EXPERIMENTAL | Each participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) in the following sequence. Sequence 1: BGF MDI HFO 320/14.4/9.6 μg BGF MDI HFA 320/14.4/9.6 μg Placebo MDI HFA |
| Treatment Sequence 2 | EXPERIMENTAL | Each participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) in the following sequence. Sequence 2: BGF MDI HFO 320/14.4/9.6 μg Placebo MDI HFA BGF MDI HFA 320/14.4/9.6 μg |
| Treatment Sequence 3 | EXPERIMENTAL | Each participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) in the following sequence. Sequence 3: BGF MDI HFA 320/14.4/9.6 μg BGF MDI HFO 320/14.4/9.6 μg Placebo MDI HFA |
| Treatment Sequence 4 | EXPERIMENTAL | Each participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) in the following sequence. Sequence 4: BGF MDI HFA 320/14.4/9.6 μg Placebo MDI HFA BGF MDI HFO 320/14.4/9.6 μg |
| Treatment Sequence 5 | EXPERIMENTAL | Each participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) in the following sequence. Sequence 5: Placebo MDI HFA BGF MDI HFO 320/14.4/9.6 μg BGF MDI HFA 320/14.4/9.6 μg |
| Treatment Sequence 6 | EXPERIMENTAL | Each participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions in the following sequence. Sequence 6: Placebo MDI HFA BGF MDI HFA 320/14.4/9.6 μg BGF MDI HFO 320/14.4/9.6 μg |
| BGF MDI HFO 320/14.4/9.6μg | EXPERIMENTAL | Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO (HFO-1234ze) |
| BGF MDI HFA 320/14.4/9.6 μg | ACTIVE_COMPARATOR | Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFA |
| Name | Type | Description |
|---|---|---|
| BGF MDI HFO 320/14.4/9.6μg | DRUG | Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart) |
| BGF MDI HFA 320/14.4/9.6 μg | DRUG | Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart): |
| Placebo MDI HFA | DRUG | Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart) |
| BGF MDI HFO 320/14.4/9.6 μg | DRUG | Budesonide, Glycopyrronium, and Formoterol Fumarate |
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: Age 1. Participants must be 40 to 80 years inclusive at the time of signing the ICF. Type of Participant and Disease Characteristics 2. Participants who have a documented history...
BGF MDI HFO 320/14.4/9.6 μg is an investigational inhaled triple-combination therapy in Phase 3 development for chronic obstructive pulmonary disease (COPD). It combines budesonide, glycopyrronium, and formoterol fumarate delivered as a metered dose inhaler using a next-generation hydrofluoroolefin (HFO) propellant. It is being developed by AstraZeneca PLC.
BGF MDI HFO 320/14.4/9.6 μg is being studied for the treatment of moderate to very severe chronic obstructive pulmonary disease (COPD). Clinical trials have enrolled adults aged 40 to 80 years with COPD. The program evaluates lung function and safety of the triple-combination formulation in this patient population.
BGF MDI HFO 320/14.4/9.6 μg is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the Phase 3 clinical program evaluating this triple-combination inhaled therapy for chronic obstructive pulmonary disease.
BGF MDI HFO 320/14.4/9.6 μg is in Phase 3 clinical development. It is investigational and has not been approved for commercial use. The Phase 3 program includes completed randomized, double-blind, controlled trials in participants with COPD.
BGF MDI HFO 320/14.4/9.6 μg has been evaluated in two completed Phase 3 trials: NCT06075095, which compared lung function effects of an approved COPD treatment (BGF with HFA propellant) versus BGF with a next-generation propellant in 297 participants, and NCT05573464, which assessed safety in 559 participants with moderate to very severe COPD.