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Pulmicort Respules

Phase 3

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Mar 25, 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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00232648Long Term Safety & Efficacy of Budesonide Inhalation Suspension in Japanese Children With Bronchial AsthmaPHASE3 COMPLETED 54Jan 1, 2004Nov 1, 2006Mar 25, 20099 Japan
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Study Endpoints
Primary Endpoints
The safety profile of long-term use of budesonide inhalation suspension assessed by evaluation of frequency and intensity of adverse events, plasma cortisol, physical examination, height, weight and clinical laboratory values.
Secondary Endpoints
The efficacy of budesonide inhalation suspension assessed by overall evaluation on asthma control by investigator
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Pulmicort (budesonide) RespulesDRUG -
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Eligibility Criteria
Age Range13 Months — 65 Months
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: \- 1. Clinical benefit from continued treatment with budesonide inhalation suspension was expected in patients with bronchial asthma participating in study SD-004-0765, as judged by the investigator(s) at the completion of that study (Visit 11, Week 24), and the patient's caregi...

Countries:Japan
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