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Salmeterol/fluticasone Diskus

Phase 3

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Jan 24, 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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment2,100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00242775Comparison of the Efficacy/Safety of Symbicort® Turbuhaler®,Seretide™ Diskus™ 50/500 µg & Terbutaline Turbuhaler® 0.4 mgPHASE3 COMPLETED 2,100May 1, 2005May 1, 2006Jan 24, 2011143 Argentina, Australia +15
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Study Endpoints
Primary Endpoints
Time to first severe asthma exacerbation
Secondary Endpoints
Number of severe asthma exacerbations
Mild asthma exacerbations
FEV1
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Budesonide/formoterol TurbuhalerDRUG -
Salmeterol/fluticasone DiskusDRUG -
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites143

Inclusion Criteria: * Diagnosed with asthma since at least 6 months prior to first visit * Prescribed daily use of glucocorticosteroids for at least 3 months prior to first visit * At least one asthma exacerbation more than one but less than twelve months prior to first visit Exclusion Criteria: ...

Countries:ArgentinaAustraliaBrazilCanadaChinaFranceGermanyIndiaIndonesiaMalaysiaMexicoPhilippinesSingaporeSouth AfricaSpainThailandVietnam
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