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fluticasone/salmeterol

Phase 3

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Aug 24, 2011

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_CONTROLLEDBiomarker
Total Trials4
Total Enrollment1,536
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00504062Open-label, Safety and Efficacy Study of Pulmicort® Turbuhaler® in Japanese Children With Bronchial AsthmaPHASE3 COMPLETED 240Oct 1, 2006Oct 1, 2007Aug 24, 20111 Japan
NCT00646594Atlantis SymbicortPHASE3 COMPLETED 1,200Nov 1, 2003Jan 1, 2005Mar 27, 2009 -
NCT00646620Symbicort Onset of Action 1PHASE3 COMPLETED 48Apr 1, 2003Sep 1, 2003Apr 6, 2009 -
NCT00646009Symbicort Onset of Action 2PHASE3 COMPLETED 48Mar 1, 2003Aug 1, 2003Jan 24, 2011 -
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Study Endpoints
Primary Endpoints
To investigate the effect of budesonide Turbuhaler® 100 μg/dose twice daily and 200 μg/dose twice daily for 6 weeks in Japanese children with bronchial asthma aged 5 years to 15 years old in need for inhaled glucocorticosteroid treatment
6 weeks
Asthma control assessed by asthma exacerbations
Continuosly throughout the treatment period
FEV1 3 minutes post dose
4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)
Secondary Endpoints
To investigate the safety of budesonide Turbuhaler 100 μg/dose twice daily and 200 μg/dose twice daily for 6 weeks in Japanese children with bronchial asthma aged 5 years to 15 years old in need for inhaled glucocorticosteroid treatment
6 weeks
To compare the efficacy of budesonide Turbuhaler 100 μg/dose twice daily and 200 μg/dose twice daily for 6 weeks to that of fluticasone Diskus® 50 μg/dose twice daily and 100 μg/dose twice daily for 6 weeks
6 weeks
Efficacy of Symbicort compared with Advair as assessed by use of rescue medication, asthma symptoms, lung function tests, quality of life reports, patient reported asthma control and patient satisfaction of Symbicort.
Daily and at 1, 3 and 6 months after start of treatmen
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALbudesonide/formoterol
2ACTIVE_COMPARATORfluticasone/salmeterol
3ACTIVE_COMPARATORalbuterol
Interventions
NameTypeDescription
budesonideDRUG -
fluticasoneDRUG -
budesonide/formoterol (Symbicort)DRUG -
fluticasone/salmeterol (Advair)DRUG -
fluticasone/salmeterol (Advair Diskus)DRUG -
albuterol (Ventolin)DRUG -
budesonide/formoterolDRUG -
fluticasone/salmeterolDRUG -
albuterolDRUG -
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Eligibility Criteria
Age Range5 Years — 15 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Provision of signed written informed consent by patient's legal representative; when possible a signed written informed consent should be obtained from the patient themselves * Patients diagnosed as having bronchial asthma regardless of type of asthma i.e. perennial or seasona...

Countries:Japan
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