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salmeterol xinafoate

Phase 3

Pulmonary Disease, Chronic Obstructive | Small molecule | Other |GSK plc|Last Updated: Apr 15, 2013

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 Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00269126Clinical Evaluation Of GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)PHASE3 COMPLETED 150Feb 1, 2005Aug 1, 2005Apr 15, 20132 Japan,
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Study Endpoints
Primary Endpoints
Change from baseline in pre-dose FEV1 at 4 weeks after starting medication of GW815SF 50/250µg
Secondary Endpoints
Change in morning PEF
Changes in pre-dose FVC, V50, V25
Use of rescue medication
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
fluticasone propionate/salmeterol combination DISKUSDRUG -
salmeterol xinafoateDRUG -
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Eligibility Criteria
Age Range40 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion criteria: * Diagnosis of COPD. Exclusion criteria: * Diagnosis of asthma or an uncontrolled medical condition or respiratory disorder other than COPD. * Other inclusion and exclusion criteria will be evaluated at the first study visit.

Countries:Japan
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