Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BGF MDI HFO 320/14.4/9.6 μg · 1 trial · 1 indication
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 |
|---|---|---|
| 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 320/14.4/9.6 μg | DRUG | Budesonide, Glycopyrronium, and Formoterol Fumarate |
| BGF MDI HFA 320/14.4/9.6 μg | DRUG | Budesonide, Glycopyrronium, and Formoterol Fumarate |
Inclusion Criteria: 1. Participant must be 40 to 80 years of age inclusive, at the time of signing the ICF; 2. Participants who have a documented history of physician-diagnosed COPD as defined by the ATS/ERS (Celli et al 2004) or by locally applicable guidelines; 3. Participants who have been regul...
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.