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GSK159797

Phase 2

Pulmonary Disease, Chronic Obstructive | Small molecule | Other |GSK plc|Last Updated: Oct 28, 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 Trials2
Total Enrollment74
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00358488Study Investigating Repeat Doses Of A New Medication (GSK159797) In Asthmatic PatientsPHASE2 COMPLETED 54Apr 1, 2006Jan 1, 2007Oct 28, 20166 Germany, Netherlands +3
NCT00354666Single Doses GSK159797 On Patient Safety And Lung Function In Patients With Mild To Moderate AsthmaPHASE2 COMPLETED 20Sep 1, 2004Dec 1, 2004Sep 1, 2016 -
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Study Endpoints
Primary Endpoints
Mean change from baseline in trough FEV1
after 14 day repeat doses
Safety and tolerability including blood test results, effects on the heart, pulse rate and blood pressure, and side effects.
Secondary Endpoints
Mean change from baseline in trough FEV1
after a single dose
Change from baseline in weighted mean FEV1 0-2 hours, 0-4 hours, 0-24 hours
Day 1 and Day 14
Effects on the lung at 12 and 24hrs Effects on the heart, blood pressure and pulse rate at 8hrs Changes in the amount of glucose and potassium in the blood 4 and 8hrs Amount of drug in the body (blood and urine).
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GSK159797 (10, 15, and 20mcg)EXPERIMENTALGSK159797 (10, 15, and 20mcg)
salbutamolEXPERIMENTALsalbutamol
salmeterol 50mcgEXPERIMENTALsalmeterol 50mcg
placeboPLACEBO_COMPARATORplacebo
Interventions
NameTypeDescription
GSK159797 (10, 15, and 20mcg)DRUGGSK159797 (10, 15, and 20mcg)
salbutamolDRUGsalbutamol
salmeterol 50mcgDRUGsalmeterol 50mcg
placeboDRUGplacebo
GSK159797DRUG -
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Eligibility Criteria
Age Range18 Years — 70 Years
SexFEMALE
Healthy VolunteersNo
Study Sites6

Inclusion criteria: * Subjects with documented history of persistent asthma using corticosteroids at a total daily dose of 200 to 200mcg of FP or equivalent corticosteroid * Female subjects only using acceptable birth control method * Non-smokers * FEV1 between 60 and 90% predicted * Increase in FE...

Countries:GermanyNetherlandsRussiaSwedenUnited Kingdom
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