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AZD8683,

Phase 2

Chronic Obstructive Pulmonary Disease (COPD) | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Mar 19, 2014

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 Enrollment28
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01205269The Study Will Evaluate the Effect of AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)PHASE2 COMPLETED 28 — — Oct 1, 2010Dec 1, 2010Mar 19, 20144 Poland
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Study Endpoints
Primary Endpoints
Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose
0, 5 min, 15 min, 30 min, 1 h, 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, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h
Forced Vital Capacity (FVC), Peak Effect Over 0 - 24 Hours Post-dose
0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h
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
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
First 50 mcg, then 200 mcg, then placeboEXPERIMENTALperiod 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4:washout, period5: placebo
First 50 mcg, then placebo, then 200 mcgEXPERIMENTALperiod 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg
First 200 mcg, then placebo, then 50 mcgEXPERIMENTALperiod 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg
First 200 mcg, then 50 mcg, then placeboEXPERIMENTALperiod 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo
First placebo, then 200 mcg, then 50 mcgEXPERIMENTALperiod 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg
First placebo, then 50 mcg, then 200 mcgEXPERIMENTALperiod 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg
Interventions
NameTypeDescription
AZD8683, 50 mcgDRUGDry powder for inhalation, single dose
PlaceboDRUGDry powder for inhalation, single dose
AZD8683, 200 mcgDRUGDry powder for inhalation, single dose
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Eligibility Criteria
Age Range40 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Clinical diagnosis of COPD * Current or ex-smokers * FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post-bronchodilator FEV1/FVC \< 70% Exclusion Criteria: * Any clinically significant disease or disorder * Any clinically relevant abnormal findings at ...

Countries:Poland
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