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ciclesonide

Phase 3

Asthma | Small molecule | Respiratory |Takeda Pharmaceutical Company Limited|Last Updated: Oct 21, 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
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00525772Effect of Ciclesonide on Exercise Induced BronchoconstrictionPHASE3 COMPLETED 26Nov 1, 2001Nov 1, 2007Oct 21, 20091 Canada
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Study Endpoints
Primary Endpoints
change in maximum fall in FEV1 induced by dry air exercise challenge after treatment compared to the respective pretreatment value
at 1 week of treatment
Secondary Endpoints
Changes in sputum cell counts,bronchial responsiveness to mannitol and other clinical parameters of asthma control after treatment compared to respective pre-treatment value.
after 1, 2, 3, weeks of treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATORciclesonide 50 and 200ug
2ACTIVE_COMPARATORciclesonide 100ug and 400ug
Interventions
NameTypeDescription
ciclesonideDRUGlow dose- 50ug and 200ug
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Eligibility Criteria
Age Range12 Years — 30 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * stable asthma not on maintenance asthma medications * exercise induced bronchoconstriction on dry air exercise challenge. Exclusion Criteria: * other significant co-morbidity or treatments that might interfere with the conduct or results of the study * fail to return to base...

Countries:Canada
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