Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BGF-MDI
BGF MDI with 10 s breath hold · 2 trials · 2 indications
Percentage of BGF MDI deposited in the lungs.
The percentage (%) emitted dose of radiolabelled BGF MDI deposited in the lungs following 10 s breath hold.
| Arm | Type | Description |
|---|---|---|
| All patients | EXPERIMENTAL | 10 patients with moderate COPD and 10 patients with severe/very severe COPD inhale BGF followed by a breath hold of up to 10 seconds. |
| Treatment Sequence 1 | EXPERIMENTAL | Subjects will receive BGF MDI with 10 s breath hold during Treatment Period 1 and BGF MDI with 3 s breath hold during Treatment Period 2 |
| Treatment Sequence 2 | EXPERIMENTAL | Subjects will receive BGF MDI with 3 s breath hold during Treatment Period 1 and BGF MDI with 10 s breath hold during Treatment Period 2 |
| Name | Type | Description |
|---|---|---|
| BGF-MDI | DRUG | Budesonide, Glycopyrronium and Formoterol Fumarate. |
| BGF MDI (budesonide, glycopyrronium and formoterol fumarate) with 10 s breath hold | DRUG | Participants will receive a single dose of BGF MDI; the dose will be administered with a 10 s breath-hold. |
| BGF MDI ((budesonide, glycopyrronium and formoterol fumarate) with 3 s breath hold | DRUG | Participants will receive a single dose of BGF MDI; the dose will be administered with a 3 s breath-hold. |
Main Inclusion Criteria: * Males and females at least 40 years of age and no older than 80 years. * Patients with diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) \[1\]. * Post bronchodilator (BD) FEV1 / Forced Vital Capacity (FVC) ratio must...
BGF MDI with 10 s breath hold is an investigational inhaled combination therapy being studied in chronic obstructive pulmonary disease (COPD). It combines budesonide, glycopyrronium and formoterol fumarate in a metered dose inhaler, and the 10 second breath hold refers to the inhalation technique evaluated in its clinical studies.
BGF MDI with 10 s breath hold is being studied for chronic obstructive pulmonary disease, or COPD. The two completed Phase 1 trials enrolled adults with COPD as well as healthy male volunteers, and assessed how the inhaled formulation distributes within the lungs when a 10 second breath hold is used.
BGF MDI with 10 s breath hold is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating this inhaled triple combination in chronic obstructive pulmonary disease.
BGF MDI with 10 s breath hold is in Phase 1 development. Both of its clinical trials are Phase 1 studies and both are completed, with no active trials currently listed. It is an investigational product and has not been approved for commercial use.
BGF MDI with 10 s breath hold has been evaluated in two completed Phase 1 trials. NCT03906045 was a scintigraphy study of PT010 in 18 COPD patients in the United Kingdom, and NCT03740373 assessed the pulmonary distribution of budesonide, glycopyrronium and formoterol fumarate in 10 healthy male volunteers.
Yes. BGF MDI with 10 s breath hold is also known as BGF MDI (budesonide, glycopyrronium and formoterol fumarate) with 10 s breath hold, or BGF-MDI. These names refer to the same AstraZeneca inhaled triple combination product and its associated clinical program in COPD.