Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BGF MDI 320/14.4/9.6 μg · 1 trial · 1 indication
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.
| 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 |
| 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 |
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% ...
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.