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PF-610,355

Phase 2

Asthma | Small molecule | Respiratory |Pfizer, Inc.|Last Updated: Nov 1, 2010

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 Enrollment42
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00468975A Blinded Study To Examine The Ability Of PF-610,355 To Open The Airways In Asthmatic Patients.PHASE2 COMPLETED 42May 1, 2007 -Nov 1, 20106 Germany, Sweden +1
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Study Endpoints
Primary Endpoints
Peak and Trough (24 hour post dose) FEV1.
Secondary Endpoints
Peak and trough (24 hour post dose) PEFR
FEV1 and PEFR measurements to 32 hours post dose.
Pharmacokinetics of PF-610,355 and salmeterol
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
PF-610,355DRUG -
SalmeterolDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Reversible asthmatic patients (\>15% increase in FEV1 following 200ug salbutamol). * FEV1 greater than or equal to 60% predicted * Stable disease for at least the previous 3 months Exclusion Criteria: * Subjects requiring rescue medication on greater than 2 occasions in the ...

Countries:GermanySwedenUnited Kingdom
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