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Bevespi

Phase 2

Chronic Obstructive Pulmonary Disease | Small molecule | Other |AstraZeneca PLC|Last Updated: Apr 23, 2026

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
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05607719Inhaled Corticosteroids (ICS) on Pulmonary Endothelial Function in COPDPHASE2 ACTIVE NOT_RECRUITING 30Apr 11, 2023Jun 30, 2026Apr 23, 20261 United States
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Study Endpoints
Primary Endpoints
Albuterol induced percent change in pulmonary vascular resistance (PVR)
baseline to 15 minutes post inhalation

Echocardiographic assessment of PVR before and after inhalation of 180 μg albuterol as a test of endothelial function

Secondary Endpoints
Albuterol induced absolute change in PVR
baseline, up to 45 minutes post inhalation
Percent change in FEV1
baseline to 15 minutes post inhalation
Change in oxygen saturation
baseline, up to 45 minutes post inhalation
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Bretzri followed by Bevespi GroupEXPERIMENTALParticipants in this group will receive Bretzri for 4-weeks followed by 8-weeks of Bevespi.
Bevespi followed by Bretzri GroupEXPERIMENTALParticipants in this group will receive Bevespi for 8-weeks followed by 4-weeks of Bretzri.
Interventions
NameTypeDescription
BevespiDRUGTwo puffs twice a day
BretzriDRUGTwo puffs twice a day
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Eligibility Criteria
Age Range40 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * physician diagnosis of COPD * former smoking history of more than 10 pack-years * baseline post-bronchodilator one-second forced expiratory volume (FEV1) 50-80% of predicted, baseline FEV1 and forced vital capacity (FVC) ratio \<0.7 * males and females, 40-80 years of age * re...

Countries:United States
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