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salmeterol

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 Trials3
Total Enrollment6,418
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00268177Airway Inflammation In Patients With Chronic Obstructive Pulmonary DiseasePHASE3 COMPLETED 130 — — Oct 1, 2002Dec 1, 2003Sep 15, 201620 Denmark, Estonia +6
NCT00268216Survival Of Subjects With Chronic Obstructive Pulmonary Disease (COPD)PHASE3 COMPLETED 6,228 — — Sep 1, 2000Nov 1, 2005Jan 20, 2017459 United States, Argentina +43
NCT00422604Safety And Efficacy Of GSK233705 Plus Salmeterol Compared With 2 Active Comparators And Placebo In Subjects With Chronic Obstructive Pulmonary Disease (COPD)PHASE2 COMPLETED 60 — — Oct 1, 2006May 1, 2007Oct 28, 201611 Finland, Germany +3
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Study Endpoints
Primary Endpoints
To compare the number of CD68+ and CD8+ inflammatory cells per area of biopsy tissue and the percentage and total number of neutrophils in induced sputum between salmeterol/fluticasone propionate and placebo
All cause mortality at 3 years
Bronchodilator effect of GSK233705 plus salmeterol at day 7, compared with placebo in COPD subjects.
Secondary Endpoints
To compare the number of mast cells, CD45+,CD4+,IFN-gamma mRNA+,TNF-alpha mRNA+, per area of biopsy and the percentage and number of macrophages, eosinophils, lymphocytes in induced sputum between salmeterol/fluticasone propionate and placebo
Rate of moderate and severe COPD exacerbations and health status assessed by the St. George's Respiratory Questionnaire.
Bronchodilator effect of salmeterol alone and tiotropium alone compared with placebo and GSK233705 at day 7. Safety and tolerability of GSK233705 plus salmeterol and the 2 active comparators at day 7.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Salmeterol/fluticasone propionate 50/500mcg DiskusDRUG -
Salmeterol 50mcg/ Fluticasone Propionate 500mcgDRUG -
salmeterolDRUG -
tiotropiumDRUG -
GSK233705DRUG -
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Eligibility Criteria
Age Range40 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: * Established clinical history of chronic obstructive airways disease. * Must be current or ex-smokers with a smoking history of at least 10 pack-years (e.g. 20 cigarettes/day for 10 years or 10 cigarettes/day for 20 years). * Must have reduced lung function, defined as a Forced...

Countries:DenmarkEstoniaFinlandItalyLithuaniaSlovakiaSpainUnited KingdomUnited StatesArgentinaAustraliaAustriaBelgiumBrazilBulgariaCanadaChileChinaCroatiaCzechiaFranceGermanyGreeceHong KongHungaryIcelandLatviaMalaysiaMexicoNetherlandsNew ZealandNorwayPakistanPhilippinesPolandPuerto RicoRomaniaRussiaSingaporeSouth AfricaSwedenTaiwanThailandUkraine
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