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Symbicort TBH - Turbuhaler

Phase 3

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Aug 14, 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
RandomizedCONTROLLED
Total Trials1
Total Enrollment430
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00628758A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent AsthmaPHASE3 COMPLETED 430Dec 1, 2005Sep 1, 2008Aug 14, 201215 Turkey (Türkiye)
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Study Endpoints
Primary Endpoints
Time to First Severe Asthma Exacerbation
26 weeks

Time to severe exacerbation among patients

Secondary Endpoints
Number of Severe Asthma Exacerbations
26 weeks
Change in Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Score
Baseline and 26 weeks
Mean Use of As-needed Medication Per Day During Treatment Period
Daily recording during the treatment period of 26 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SymbicortEXPERIMENTALSymbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)
Conventional BPEXPERIMENTALConventional Best Practice for Treatment of Asthma
Interventions
NameTypeDescription
Symbicort TBH - TurbuhalerDRUGSymbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)
beta-II-agonist, inhale steroidDRUGSalbulin inh. 200-400 dosage 100 microgram (mcg)/dosage Salbutamol Sustained Release(SR)capsule 4 mg/8 mg Salbutol tablet (tb) 2 mg Salbutol forte syrup 2 mg/5 ml Ventolin tb, syrup, intravenous(IV),5mgx10 ampule(amp) Ventolin inhaler (inh) 200 dosage, 100 mcg/dosage Ventolin nebul 2.5 mg Volmax tb 4 mg/8 mg Vent-o-sal inh 100 mcg/200 dosage Combivent inh 100 mcg/dosage Combivent neb 2.5 mg/dosage Bricanyl tb 2.5 mg Bricanyl durules ret tb 5 mg Bricanyl syrup 30mg Bricanyl inhaler 0.25 mg/dosage, 400 dosage Bricanyl turbuhaler 0.5 mg/dosage, 200dosage
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Signed informed consent form. If the patient cannot read and write, verbal consent from the patient is required. * Ability to read and write in Turkish * Female or male outpatients aged 18 years * Minimum of 3 months history of asthma, diagnosed according to the American Thora...

Countries:Turkey (Türkiye)
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