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Fluticasone Discus 250 µg

Phase 3

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Mar 17, 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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment1,600
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00252863DESOLO - SiT Peri-Launch: A Comparison of Symbicort Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma in AdultsPHASE3 COMPLETED 1,600Dec 1, 2004May 1, 2006Mar 17, 2009169 Germany
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Study Endpoints
Primary Endpoints
Time to first severe asthma exacerbation
Secondary Endpoints
Number of severe asthma exacerbations
Mean use of as-needed medication
Change in forced expiratory volume in 1 second (FEV1) from the end of run-in to the end of the study period
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Symbicort, used twice daily (b.i.d) and as needed (prn)DRUG -
Budesonide Turbuhaler 200 µgDRUG -
Fluticasone Discus 250 µgDRUG -
Formoterol Turbuhaler 4.5 µgDRUG -
Terbutaline Turbuhaler 0.5 mgDRUG -
Salbutamol pressurized metered dose inhaler (pMDI) 100 µgDRUG -
Salmeterol Discus 50 µgDRUG -
Budesonide/Formoterol Turbuhaler 160/4.5 µgDRUG -
Fluticasone/Salmeterol Discus 250/50 µgDRUG -
Fluticasone/Salmeterol Discus 500/50 µgDRUG -
Theophylline 200 mgDRUG -
Theophylline 300 mgDRUG -
Singulair 10 mgDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites169

Inclusion Criteria: * Patients with asthma, either well-controlled on a regular therapy with a combination of long-acting beta-agonists and inhaled corticosteroids or symptomatic on therapy with inhaled corticosteroids alone. Exclusion Criteria: * Any other significant lung disease other than ast...

Countries:Germany
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