Recent Updates
Recently added Catalysts

BGF

Phase 3

Chronic Obstructive Pulmonary Disease (COPD) | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Feb 11, 2021

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment23

FDA Designations

No designations recorded

Clinical trial landscape

BGF · 1 trial · 1 indication

Phase 3 1
NCT03836677A Study to Evaluate the Effects of BGF and GFF on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPDChronic Obstructive Pulmonary Disease (COPD)
COMPLETED23 Analytics
PHASE3COMPLETED
A Study to Evaluate the Effects of BGF and GFF on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD
Chronic Obstructive Pulmonary Disease (COPD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Specific Image-based Airway Volume (siVaw)
Baseline, Day 29

Specific image-based airway volume (SiVaw) measured in mL/L. Average across lobes, adjusted for lobe volume. Reported as ratio to baseline.

Specific Image-based Airway Resistance (siRaw)
Baseline, Day 29

Specific image-based airway resistance (siRaw) measured in kPa∙s. Average across lobes, adjusted for lobe volume. Reported as ratio to baseline.

Secondary Endpoints

Image-based Airway Volume (iVaw)
Baseline, Day 29
Image-based Airway Resistance (iRaw)
Baseline, 29 Days
Forced Expiratory Volume in One Second (Post-dose FEV1).
Baseline 29 Days
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BGF-GFFEXPERIMENTALSubject first treated with Budesonide/Glycopyrronium/Formoterol Fumarate followed by a washout period then treated with Glycopyrronium/Formoterol Fumarate
GFF-BGFEXPERIMENTALSubject first treated with Glycopyrronium/Formoterol Fumarate followed by a washout period then treated with Budesonide/Glycopyrronium/Formoterol Fumarate

Interventions

NameTypeDescription
BGFCOMBINATION_PRODUCTTreatment with Budesonide/Glycopyrronium/FormoterolFumarate
GFFCOMBINATION_PRODUCTTreatment with Glycopyrronium/Formoterol Fumarate
Unlock Study Design Details

Eligibility Criteria

Age Range40 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: Subject must be 40 years to ≤80 years of age inclusive, at the time of signing the informed consent form at Visit 1. * COPD Diagnosis: Subjects with an established clinical history of COPD * Screening clinical laboratory tests must be acceptable to the Investigator. * Screening...

Countries:BelgiumNetherlands
Unlock Eligibility Criteria

Frequently asked questions about BGF

What is BGF used for in COPD?

BGF is an investigational small molecule being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is currently in Phase 3 clinical development, though the specific trial data provided has been completed. BGF is not approved and remains under investigation for this respiratory condition.

Who makes BGF?

BGF is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical research on BGF for the treatment of Chronic Obstructive Pulmonary Disease (COPD).

What phase is BGF in?

BGF is in Phase 3 clinical development for Chronic Obstructive Pulmonary Disease (COPD). The Phase 3 trial listed has been completed, but BGF remains an investigational drug and is not yet approved for any use.

What clinical trials is BGF in?

BGF has one completed Phase 3 clinical trial registered under NCT03836677, titled 'A Study to Evaluate the Effects of BGF and GFF on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD.' The trial enrolled 23 participants in Belgium and the Netherlands.

Is BGF the same as GFF?

No, BGF is not the same as GFF. In the clinical trial NCT03836677, BGF and GFF are evaluated as separate treatments for Chronic Obstructive Pulmonary Disease (COPD). The study compares the effects of BGF and GFF on airway volumes and resistance.

What is the design of the BGF clinical trial?

The BGF Phase 3 trial NCT03836677 is a randomized, double-blind, controlled study in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). It enrolled 23 adults aged 40 years and older, of all sexes, at sites in Belgium and the Netherlands. The trial has been completed.