Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BGF MDI HFO 320/14.4/9.6μg · 1 trial · 1 indication
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
| 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 |
| 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) |
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 used for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is a fixed-dose combination of budesonide, glycopyrronium, and formoterol fumarate delivered via a metered-dose inhaler with a next-generation propellant. The drug is being developed for patients with moderate to very severe COPD.
BGF MDI HFO 320/14.4/9.6 μg combines three active ingredients: budesonide, an inhaled corticosteroid; glycopyrronium, a long-acting muscarinic antagonist; and formoterol fumarate, a long-acting beta-2 agonist. Together, these target inflammation, bronchoconstriction, and airway smooth muscle tone to improve lung function in COPD patients.
BGF MDI HFO 320/14.4/9.6 μg is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting Phase 3 clinical trials to evaluate the safety and efficacy of this combination therapy for COPD.
BGF MDI HFO 320/14.4/9.6 μg is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 3 trials have been completed, both evaluating the drug in patients with COPD.
BGF MDI HFO 320/14.4/9.6 μg has been studied in two completed Phase 3 trials. NCT05573464 assessed safety in 559 participants with moderate to very severe COPD. NCT06075095 investigated lung function effects in 297 participants aged 40 to 80 with COPD, comparing the drug to an approved BGF formulation with HFA propellant.
Yes, BGF MDI HFO 320/14.4/9.6 μg is the same as budesonide/glycopyrronium/formoterol fumarate. The acronym BGF stands for the three active ingredients: budesonide, glycopyrronium, and formoterol fumarate. The formulation uses a next-generation propellant in a metered-dose inhaler for COPD treatment.