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cilomilast

Phase 3

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment600
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00103922Study In Subjects With COPD (Chronic Obstructive Pulmonary Disease)PHASE3 COMPLETED 600Nov 1, 2004Jan 1, 2007Oct 28, 2016115 United States
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Study Endpoints
Primary Endpoints
measure of lung function and quality of life in patients with COPD
Secondary Endpoints
exacerbations in patients with COPD
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTAL -
Interventions
NameTypeDescription
cilomilastDRUG -
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Eligibility Criteria
Age Range40 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites115

Inclusion criteria: * Diagnosis of COPD and a history of cigarette smoking. Exclusion criteria: * Significant heart or lung disease not associated with COPD. * Significant stomach or intestinal disease.

Countries:United States
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