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 is an investigational small molecule being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is intended for patients with COPD, a progressive lung disease that causes breathing difficulties.
BGF-MDI is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca is conducting clinical research on this investigational drug for the treatment of Chronic Obstructive Pulmonary Disease.
BGF-MDI is in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. The Phase 1 trial for BGF-MDI has been completed, and the drug is still in the early stages of clinical testing for Chronic Obstructive Pulmonary Disease.
BGF-MDI has one completed Phase 1 clinical trial with the identifier NCT03906045, titled 'A Scintigraphy Study of PT010 in COPD Patients'. This trial enrolled 18 participants in the United Kingdom and studied the drug in patients with Chronic Obstructive Pulmonary Disease. The trial was not randomized, double-blind, or controlled.
Yes, BGF-MDI is also known as PT010. The completed Phase 1 clinical trial for BGF-MDI, with identifier NCT03906045, is titled 'A Scintigraphy Study of PT010 in COPD Patients', confirming that PT010 is an alternative name for this investigational drug being developed by AstraZeneca.