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Ciclesonide HFA

Phase 2

Rhinitis, Allergic, Seasonal | Small molecule | Other |AstraZeneca PLC|Last Updated: Dec 5, 2016

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment480
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00807053Dose-ranging Study to Assess the Efficacy and Safety of Ciclesonide HFA Nasal Aerosol in Adult and Adolescent Patients 12 Years and Older With Seasonal Allergic Rhinitis (SAR) (BY9010/M1-602)PHASE2 COMPLETED 480 — — Apr 1, 2007Jul 1, 2007Dec 5, 201631 United States
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Study Endpoints
Primary Endpoints
Average of AM and PM patient-reported reflective Total Nasal Symptom Score (TNSS) over the first two weeks of treatment
2 weeks
Secondary Endpoints
Average of AM and PM patient-reported instantaneous TNSS over the first two weeks of treatment
2 weeks
Physician-assessed total nasal symptoms score (PNSS) over the treatment period
4 weeks
Rhinoconjunctivitis Quality of Life Questionaire (RQLQ) over the treatment period in patients (adolescents and adults) with impaired quality of life at Baseline defined as a RQLQ score of greater than 3.0
4 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATORCiclesonide HFA 75 mcg (37,5 mcg / actuation, 1 actuation/nostril), once daily
2ACTIVE_COMPARATORCiclesonide HFA 150 mcg (75 mcg / actuation, 1 actuation/nostril), once daily
3ACTIVE_COMPARATORCiclesonide HFA 300 mcg (150 mcg / actuation, 1 actuation/nostril), once daily
4PLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
Ciclesonide HFADRUG75 mcg Ciclesonide HFA versus Placebo
PlaceboDRUGPlacebo
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites31

Inclusion Criteria: 1. Male or female 12 years and older 2. General good health, and free of any concomitant conditions or treatment that could interfere with study conduct,influence the interpretation of study observations/results, or put the patient at increases risk during the trial 3. A history...

Countries:United States
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