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fluticasone propionate DISKUS

Phase 3

Pulmonary Disease, Chronic Obstructive | Small molecule | Other |GSK plc|Last Updated: Jan 20, 2017

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 Enrollment290
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00549146Treatment Of Partial Reversible Chronic Obstructive Pulmonary DiseasePHASE3 COMPLETED 290 — — Nov 1, 2003Apr 1, 2006Jan 20, 201717 Netherlands
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Study Endpoints
Primary Endpoints
Difference in efficacy of a 12 months treatment with salmeterol/fluticasone combination versus fluticasone on lung function (FEV1) as percentage predicted.
Secondary Endpoints
Reversibility of lung function with salbutamol and on Forced Vital capacity (FVC), TLC, FRC, FVC, Inspiration capacity(IC), Forced Inspiratory Volume in 1 second (FIV1) and Maximum mid-Expiratory Flow (MEF50).
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
fluticasone propionate/salmeterol 250/50 DISKUS combination productDRUG -
fluticasone propionate DISKUS 500mcgDRUG -
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Eligibility Criteria
Age Range40 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion criteria: * Established history of chronic obstructive pulmonary disease (COPD). * Lung function parameters: FEV1/FVC ratio \< 70%, FEV1 between 80% and 30% predicted, a reversibility of airway obstruction of 12% of the initial value with a minimum of 200 mL. * Signed and dated informed c...

Countries:Netherlands
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