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BGF-MDI

Phase 1

Chronic Obstructive Pulmonary Disease | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Feb 12, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

BGF-MDI · 1 trial · 1 indication

Phase 1 1
NCT03906045A Scintigraphy Study of PT010 in COPD PatientsChronic Obstructive Pulmonary Disease
COMPLETED18 Analytics
PHASE1COMPLETED
A Scintigraphy Study of PT010 in COPD Patients
Chronic Obstructive Pulmonary DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

The percentage (%) emitted dose of radiolabelled BGF MDI deposited in the lungs following a maximal breath-hold of up to 10 s.
Day 1

Percentage of BGF MDI deposited in the lungs.

Secondary Endpoints

Regional airway deposition ratios including the non-normalized parameters O/I and C/P regions and the normalized parameters PI and sC/P of the radiolabelled BGF MDI following a maximal breath-hold of up to 10 s.
Day 1
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
All patientsEXPERIMENTAL10 patients with moderate COPD and 10 patients with severe/very severe COPD inhale BGF followed by a breath hold of up to 10 seconds.

Interventions

NameTypeDescription
BGF-MDIDRUGBudesonide, Glycopyrronium and Formoterol Fumarate.
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Eligibility Criteria

Age Range40 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites2

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...

Countries:United Kingdom
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Frequently asked questions about BGF-MDI

What is BGF-MDI used for?

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.

Who makes BGF-MDI?

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.

What phase is BGF-MDI in?

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.

What clinical trials is BGF-MDI in?

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.

Is BGF-MDI the same as PT010?

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.