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GW870086

Phase 2

Asthma | Small molecule | Respiratory |GSK plc|Last Updated: Dec 1, 2016

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 Trials1
Total Enrollment136
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01245426A Study in Asthmatics to Determine the Efficacy and Dose Response of Repeat Doses of GW870086X on Forced Expiratory Volume in 1 Second (FEV1)PHASE2 COMPLETED 136Dec 1, 2010Aug 1, 2011Dec 1, 201611 Bulgaria, Germany +1
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Study Endpoints
Primary Endpoints
Change from baseline associated with GW870086X versus placebo at Day 28 on FEV1
Day 28
Secondary Endpoints
Change from baseline in FEV1 on Day 7, Day 14 and Day 21
Days; 7, 14, 21
Change from baseline in peak expiratory flow rate (PEFR) measured twice daily over 28 days
Days 1-28
Rescue medication usage
Days 1-28
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GW870086 2mgEXPERIMENTALGW870086 2mg once daily in the morning for 27 ± 2 days
GW870086 4mgEXPERIMENTALGW870086 4mg once daily in the morning for 27 ± 2 days
PlaceboPLACEBO_COMPARATORPlacebo once daily in the morning for 27 ± 2 days
GW870086 1mgEXPERIMENTALGW870086 1mg once daily in the morning for 27 ± 2 days
GW870086 3mgEXPERIMENTALGW870086 3mg once daily in the morning for 27 ± 2 days
Interventions
NameTypeDescription
GW870086 2mgDRUGoral inhalation
GW870086 4mgDRUGoral inhalation
GW870086 PlaceboDRUGoral inhalation
GW870086 1mgDRUGoral inhalation
GW870086 3mgDRUGoral inhalation
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Male or female between 18 and 65 years * A female subject is eligible to participate if she is of: Non-childbearing potential. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to discontinue HRT to allow confirmation of post...

Countries:BulgariaGermanySouth Africa
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