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AZD9164

Phase 2

Chronic Obstructive Pulmonary Disease | Small molecule | Other |AstraZeneca PLC|Last Updated: Aug 5, 2011

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 Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00939211The Study Will Evaluate the Effect of AZD9164 in Patients With Chronic Obstructive Pulmonary DiseasePHASE2 COMPLETED 25 — — Jun 1, 2009Nov 1, 2009Aug 5, 20113 Sweden
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Study Endpoints
Primary Endpoints
Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose
0, 15 min, 30 min, 60 min, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h

Maximum FEV1 value

Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose
22 h, 24 h, 26 h

Trough FEV1 value

Secondary Endpoints
Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post Dose
0, 15 min, 30 min, 60 min, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h
Forced Expiratory Volume in One Second (FEV1), Effect at 15 Minutes Post-dose
15 min
Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose
0, 30 min, 2 h, 4 h
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AZD9164 100 mcg First, then Placebo for SpririvaEXPERIMENTAL1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
AZD9164 400 mcg First, then Placebo for SpirivaEXPERIMENTAL1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
AZD9164 1200 mcg First, then Placebo for SpirivaEXPERIMENTAL1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
Spiriva 18 mcg First, then Placebo for AZD9164ACTIVE_COMPARATOR1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
Placebo for Spiriva First, then Placebo for AZD9164PLACEBO_COMPARATOR1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
Interventions
NameTypeDescription
AZD9164DRUGSolution for inhalation through nebulization, single dose
TiotropiumDRUGDry powder for inhalation, single dose
PlaceboDRUGPlacebo
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Eligibility Criteria
Age Range40 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * A clinical diagnosis of COPD * FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post- bronchodilator FEV1/FVC \< 70% Exclusion Criteria: * Any clinically relevant abnormal findings at screening examinations * Any clinically significant disease or disorde...

Countries:Sweden
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