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AZD1981,

Phase 2

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Feb 26, 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment412
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00758589One Month Dose Response Study of AZD1981 in Asthma Patients Uncontrolled on Inhaled SteroidsPHASE2 COMPLETED 368Sep 1, 2008Jul 1, 2009Feb 26, 201421 Argentina, Brazil +2
NCT01265641To Investigate the Effects of AZD1981 on the QT IntervalPHASE1 COMPLETED 44Jan 1, 2011Apr 1, 2011Jun 28, 20111 United Kingdom
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Study Endpoints
Primary Endpoints
Morning Peak Expiratory Flow (mPEF)
Week 4

Mean mPEF during the treatment period (mean of the last 2 weeks of the treatment period)

To evaluate the effect of a single supra maximal therapeutic dose of AZD1981on QT interval - QTcF
dECG and telemetry measurements taken pre-dose and up to and including 48 hours post dose
Secondary Endpoints
Evening Peak Expiratory Flow (ePEF)
Week 4
Morning Forced Expiratory Volume in 1 Second (mFEV1)
Week 4
Evening Forced Expiratory Volume in 1 Second (eFEV1)
Week 4
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AZD1981 50 mgEXPERIMENTALAZD1981 50 mg Twice Daily (Bid)
PlaceboPLACEBO_COMPARATORPlacebo
AZD1981 400 mgEXPERIMENTALAZD1981 400 mg Twice Daily (Bid)
AZD1981 1000 mgEXPERIMENTALAZD1981 1000 mg Twice Daily (Bid)
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -
4PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
AZD1981DRUGOral tablet, 50 mg twice daily
PlaceboDRUG -
AZD1981, 2000mgDRUGSingle oral dose, tablets
AZD1981, 200mgDRUGSingle oral dose, tablets
Moxifloxacin, 400mgDRUGSingle oral dose, capsule
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Six months history of asthma * Daily use of inhaled glucocorticosteroids * FEV1 40-85% of predicted normal * Reversibility; increase in FEV1 more than 12% and 200 mL post-bronchodilator Exclusion Criteria: * Other clinically relevant disease or disorders * History of smoking...

Countries:ArgentinaBrazilCosta RicaPolandUnited Kingdom
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