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BGF-MDI

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03906045A Scintigraphy Study of PT010 in COPD PatientsPHASE1 COMPLETED 18Apr 4, 2019Mar 5, 2020Feb 12, 20212 United Kingdom
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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 — 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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