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corticosteroid therapy

Phase 1

Bronchial Asthma | Small molecule | Respiratory |Novartis AG|Last Updated: Jun 22, 2007

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 Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00411567A Study to Assess the Efficacy of Inhaled Corticosteroid (ICS) Therapy in Moderate-Severe Bronchial AsthmaPHASE1 COMPLETED 26 — — Jul 1, 2006 -Jun 22, 20071 Germany
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Study Endpoints
Primary Endpoints
Change in inflammatory parameters in response to a decrease in ICS compared to no change in therapy after 2 and 4 weeks
Secondary Endpoints
Parameter/combination of parameters most sensitive to the ICS reduction
Collection of relative data to assess sample size calculations for subsequent studies
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
inhaled corticosteroid therapyDRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male and/or female moderate to severe asthmatic patients, from 18-75 years of age. * Moderate to severe asthma, according to the GINA guidelines, for at least one year with no exacerbations requiring hospitalization and/or oral steroids within the previous three months. * No c...

Countries:Germany
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