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GW685698X Aqueous

Phase 3

Rhinitis, Allergic, Seasonal | Small molecule | Other |GSK plc|Last Updated: Aug 31, 2018

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-BlindUNCONTROLLED
Total Trials3
Total Enrollment706
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00197262Once-Daily Investigational Nasal Spray In Adults And Adolescents With Seasonal Allergic Rhinitis (SAR)PHASE3 COMPLETED 288 — — Aug 1, 2005Oct 1, 2005Jan 19, 201718 United States
NCT00118729Study In Adolescent And Adult Subjects 12 Years Of Age And Older With Seasonal Allergic Rhinitis To Assess Onset of ActionPHASE3 COMPLETED 380 — — Apr 1, 2005Aug 1, 2005Sep 15, 20161 United States
NCT00363740Study of GW685698X In Patients With Seasonal Allergic RhinitisPHASE3 COMPLETED 38 — — Feb 19, 2005Apr 13, 2005Aug 31, 20181
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Study Endpoints
Primary Endpoints
Mean change from baseline over the entire treatment period in daily, reflective total nasal symptom scores.
Mean change from baseline in subject-rated total nasal symptom score following a single dose of GW685698X aqueous nasal spray during exposure to ragweed pollen over a 12-hour period.
Mean change from baseline over the entire treatment period in three total nasal symptom scores.
Secondary Endpoints
1) Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous total nasal symptom scores. 2) Mean change from baseline in daily reflective total ocular symptom scores. 3) overall evaluation of response to therapy.
Change from baseline in the individual nasal symptom scores of rhinorrhea, nasal congestion, nasal itching and sneezing, assessed hourly during the 12-hour, post-dose exposure period to ragweed pollen in the allergen challenge chamber.
Mean change from baseline over the entire treatment period in four total nasal symptom scores.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTAL -
Interventions
NameTypeDescription
GW685698X Aqueous Nasal SprayDRUG -
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion criteria: * Must be outpatients. * Diagnosis of SAR. * Literate in English or native language. Exclusion criteria: * Have a significant concomitant medical condition. * Use corticosteroids or other allergy medications during the study. * Use tobacco products.

Countries:United States
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