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terbutaline

Phase 3

Chronic Obstructive Pulmonary Disease | Small molecule | Other |AstraZeneca PLC|Last Updated: Mar 27, 2009

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-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment315
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00421122Efficacy and Safety Study of Symbicort Turbuhaler in Chinese Patients With COPDPHASE3 COMPLETED 315Sep 1, 2006Nov 1, 2007Mar 27, 20098 China
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Study Endpoints
Primary Endpoints
Post-study medication FEV1
1 hour after medication
Secondary Endpoints
FVC
Pre dose and 1 hour post dose
FEV1
Pre-dose and 15 minutes post dose
SGRQ symptom scores
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATORBricasol®
2EXPERIMENTALBricasol® + Pulmicort®
3EXPERIMENTALBricasol® + Symbicort®
Interventions
NameTypeDescription
budesonide/formoterol (Symbicort)DRUGinhalation therapy
budesonide (Pulmicort)DRUGinhalation
terbutaline sulfate (Bricasol)DRUGinhalation therapy
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Eligibility Criteria
Age Range40 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Signed and dated inform consent * Out-patient, clinical diagnosis of COPD * Men or women at the age of 40 or over Exclusion Criteria: * A history of asthma * Seasonal allergic rhinitis before 40 years of age * Patients with significant or unstable ischemic heart disease, arr...

Countries:China
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