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Terbutaline sulphate

Phase 3

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Jan 13, 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment95
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02322788Comparing the Efficacy of Bricanyl M2 and Bricanyl M3 at 0.5 and 1.5 mg Dose Levels, to Allow for a Switch From Bricanyl Turbuhaler M2 to Bricanyl Turbuhaler M3PHASE3 COMPLETED 95Mar 1, 2015Nov 1, 2015Jan 13, 20174 Canada, Netherlands +1
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Study Endpoints
Primary Endpoints
Provocative Concentration of Methacholine Which Produces a 20% Fall in FEV1 (PC20)
4 cross-over treatments (<1 day each) with 2-10 days between treatment washout periods
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Bricanyl Turbuhaler M2, ActiveACTIVE_COMPARATORTerbutaline sulphate powder for inhalation, 0.5 mg terbutaline per inhalation
Bricanyl Turbuhaler M3, ActiveACTIVE_COMPARATORTerbutaline sulphate powder for inhalation, 0.4 mg terbutaline per inhalation
Turbuhaler M2, PlaceboPLACEBO_COMPARATORPlacebo powder for inhalation
Turbuhaler M3, PlaceboPLACEBO_COMPARATORPlacebo powder for inhalation
Interventions
NameTypeDescription
Terbutaline sulphateDRUGBricanyl Turbuhaler M2
Placebo for terbutaline sulphateDRUGPlacebo Turbuhaler M2
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: - Female and male aged 18 and 65 years. * At least 6 months of documented clinical diagnosis of asthma as defined by GINA 2012 or American Thoracic Society (Expert Panel Report 3 2007) prior to visit 1 * Stable asthmatics on SABA alone, on low dose ICS (200-400 µg budesonide cor...

Countries:CanadaNetherlandsSweden
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