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AZD8871 100 µg

Phase 2

Chronic Obstructive Pulmonary Disease COPD | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Jun 18, 2019

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment42
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02971293Efficacy, Pharmacokinetics (PK), Safety and Tolerability Study of Inhaled AZD8871PHASE2 COMPLETED 42 — — Dec 15, 2016Aug 18, 2017Jun 18, 20192 Germany, United Kingdom
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Study Endpoints
Primary Endpoints
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1)
On Day 15

The efficacy of inhaled AZD8871 in patients with moderate to severe COPD was assessed by measuring the change in trough FEV1 on Day 15

Secondary Endpoints
Observed Maximum Plasma (Cmax) of AZD8871 and Its Metabolites (Single Dose)
Pre-dose and 30 min, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1.
Observed Maximum Plasma (Cmax) of AZD8871 and Its Metabolites (Multiple Doses, Day 14)
Pre-dose and 30 min, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Day 14.
Time to Reach Maximum Plasma Concentration (Tmax) of AZD8871 and Its Metabolites (Single Dose)
Pre-dose and 30 min, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AZD8871 100 µgEXPERIMENTALThe subjects will receive AZD8871 100 µg once daily, by dry powder inhaler (DPI) device. The treatment will be administered via single dose DPI that is an adaptation of the multi-dose Genuair™ used in approved inhalation products.
PlaceboPLACEBO_COMPARATORThe placebo will be administered via single dose DPI that is an adaptation of the commercially available Genuair® with a smaller internal volume to enable delivery of single doses. To maintain blinding, each patient will receive one inhaled dose from placebo DPI provided to him/her on each day of the treatment period.
AZD8871 600 µgEXPERIMENTALThe subjects will receive AZD8871 600 µg once daily by DPI device via single dose DPI that is an adaptation of the multi-dose Genuair™ used in approved inhalation products.
Interventions
NameTypeDescription
AZD8871 100 µgDRUGThe subjects will receive one dose of AZD8871 100 µg single dose DPI.
AZD8871 600 µgDRUGThe subjects will receive AZD8871, 600 µg single dose DPI.
PlaceboDRUGThe subject will receive Placebo single dose DPI.
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Eligibility Criteria
Age Range40 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Patient who provided of informed consent prior to any study-specific procedures 2. Male or female 40 to 80 years of age (both inclusive) at Screening (Visit 1). A female is eligible to enter and participate in the study if she is of non-childbearing potential. Note: A fem...

Countries:GermanyUnited Kingdom
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