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Terbutaline Turbuhaler

Phase 3

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Aug 31, 2012

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-BlindCONTROLLEDBiomarker
Total Trials2
Total Enrollment124
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01096017To Investigate the Relative Efficacy of Terbutaline Turbuhaler® and Salbutamol Pressurized Metered Dose Inhaler (pMDI) a Single Blind StudyPHASE3 COMPLETED 24Mar 1, 2010Apr 1, 2010Aug 31, 20121 Japan
NCT00244608A Comparison of the Control of Asthma Provided by Symbicort® Turbuhaler® Versus Symbicort® Turbuhaler® Plus Pulmicort® Turbuhaler® Plus Terbutaline Turbuhaler®PHASE3 COMPLETED 100May 1, 2005Mar 1, 2007Jan 24, 201122 Denmark, France +4
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Study Endpoints
Primary Endpoints
FEV1 (Forced Expiratory Volume in 1 Second) Area Under Curve (AUC) 0-4 Hours After Drug Inhalation
At two visits during a maximum of 15 days. FEV1 timepoints: all time points t=5, 15, 30, 60, 120, 180 and 240 minutes.

FEV1 (Forced Expiratory Volume in 1 second) AUC 0-4 hours after drug inhalation

Change in eosinophils in bronchial biopsies (first and last visit) and in sputum (5 times during the 12-month treatment period)
Secondary Endpoints
FEV1 (Forced Expiratory Volume in 1 Second) at 5 Minutes After Inhalations of Study Drug as Percentage of Pre-dose
At two visits during a maximum of 15 days
FEV1 (Forced Expiratory Volume in 1 Second) at 15 Minutes After Inhalations of Study Drug as Percentage of Pre-dose
At two visits during a maximum of 15 days
FEV1 (Forced Expiratory Volume in 1 Second) at 30 Minutes After Inhalations of Study Drug as Percentage of Pre-dose
At two visits during a maximum of 15 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALTerbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI ⇒salbutamol pMDI 200 μg +placebo Turbuhaler®
2EXPERIMENTALsalbutamol pMDI 200 μg +placebo Turbuhaler® ⇒Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI
Interventions
NameTypeDescription
Terbutaline Turbuhaler®DRUG0.4 mg, inhalation, single dose
Salbutamol pMDIDRUG200 μg, inhalation, single dose
pMDI placebo pMDIOTHERPlacebo pMDI 2 inhalations
Placebo Turbuhaler®OTHERPlacebo Turbuhaler 1 inhalation
Budesonide/Formoterol TurbuhalerDRUG -
Budesonide Turbuhaler (Pulmicort)DRUG -
Terbutaline TurbuhalerDRUG -
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Eligibility Criteria
Age Range16 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * On ICS for at least 3 months from Visit 2 and with a prescribed constant dose during the 4 weeks prior to Visit 2 * Forced Expiratory Volume in 1 Second (FEV1) of at least 50 % of predicted normal value pre-bronchodilator * Reversible airway obstruction according to reversibil...

Countries:JapanDenmarkFranceGermanySpainSwedenUnited Kingdom
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