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Budesonide+ Azelastine

Phase 2

Seasonal Allergic Rhinitis | Small molecule | Respiratory |Ligand Pharmaceuticals Incorporated|Last Updated: Oct 4, 2012

Target and mechanism

ModalitySmall molecule

Also known as Budesonide

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment173

FDA Designations

No designations recorded

Clinical trial landscape

Budesonide+ Azelastine · 2 trials · 1 indication

Phase 2 2
NCT00940953Compare Captisol-Enabled (CE) Budesonide + Azelastine Nasal Solution and Rhinocort Aqua + Astelin in an Environmental Exposure Chamber (EEC) Study of Allergic RhinitisSeasonal Allergic Rhinitis
COMPLETED108 Analytics
NCT00938613Compare CE-Budesonide Nasal Solution & Rhinocort Aqua in an EEC Study of ARSeasonal Allergic Rhinitis
COMPLETED65 Analytics
PHASE2COMPLETED
Compare Captisol-Enabled (CE) Budesonide + Azelastine Nasal Solution and Rhinocort Aqua + Astelin in an Environmental Exposure Chamber (EEC) Study of Allergic Rhinitis
Seasonal Allergic Rhinitis
NCT00940953108
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PHASE2COMPLETED
Compare CE-Budesonide Nasal Solution & Rhinocort Aqua in an EEC Study of AR
Seasonal Allergic Rhinitis
NCT0093861365
Unlock trial analytics

Study Endpoints

Primary Endpoints

Patient-rated Total Nasal Symptom Score
10 mins, 20 mins, 30 mins, 40 mins, 60 mins, 90 mins, 120 mins and then every hour up to 10 hours post dose
Total Nasal Symptom Score
15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins, and then every hour up to 10 hours post dose

Secondary Endpoints

Patient-rated Total Symptom Score
10 mins, 20 mins, 30 mins, 40 mins, 60 mins, 90 mins, 120 mins and then every hour up to 10 hours post dose
Patient-rated EEC-RQLQ assessment
-0.75 hours, 2 hours, 6 hours and 10 hours post dose
Onset of action of active treatments as compared to placebo
15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins and then every hour up to 10 hours post dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Captisol-Enabled Budesonide + AzelastineEXPERIMENTAL -
Rhinocort Aqua+AstelinACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
Captisol-Enabled BudesonideEXPERIMENTAL32 ug/spray
Rhinocort AquaACTIVE_COMPARATOR32 ug/spray

Interventions

NameTypeDescription
Budesonide + AzelastineDRUGnasal spray, one spray per nostril at time 0 plus one spray Placebo
PlaceboDRUGnasal spray, one spray per nostril from each of 2 bottles at time 0
BudesonideDRUGnasal spray, one spray per nostril at time 0
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients must have a clinical history of SAR * Adults (males and females) aged 18 to 65 * Patients must have documentation of a positive skin test within 12 months of screening to ragweed allergen defined by a positive case history and a positive skin prick and/or intradermal ...

Countries:Canada
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