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GW685698X Aqueous

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials3
Total Enrollment706

FDA Designations

No designations recorded

Clinical trial landscape

GW685698X Aqueous · 5 trials · 2 indications

Phase 3 5
NCT00197262Once-Daily Investigational Nasal Spray In Adults And Adolescents With Seasonal Allergic Rhinitis (SAR)Rhinitis, Allergic, Seasonal
COMPLETED288 Analytics
NCT00118729Study In Adolescent And Adult Subjects 12 Years Of Age And Older With Seasonal Allergic Rhinitis To Assess Onset of ActionRhinitis, Allergic, Seasonal
COMPLETED380 Analytics
NCT00363740Study of GW685698X In Patients With Seasonal Allergic RhinitisRhinitis, Allergic, Seasonal
COMPLETED38 Analytics
NCT00116883A Study Of GW685698X For The Treatment Of Perennial Allergic Rhinitis In PediatricsRhinitis, Allergic, Perennial
COMPLETED90 Analytics
NCT00116818A Study of GW685698X for the Treatment Of Perennial Allergic Rhinitis in Adolescents and AdultsRhinitis, Allergic, Perennial
COMPLETED90 Analytics
PHASE3COMPLETED
Once-Daily Investigational Nasal Spray In Adults And Adolescents With Seasonal Allergic Rhinitis (SAR)
Rhinitis, Allergic, Seasonal
NCT00197262288
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PHASE3COMPLETED
Study In Adolescent And Adult Subjects 12 Years Of Age And Older With Seasonal Allergic Rhinitis To Assess Onset of Action
Rhinitis, Allergic, Seasonal
NCT00118729380
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PHASE3COMPLETED
Study of GW685698X In Patients With Seasonal Allergic Rhinitis
Rhinitis, Allergic, Seasonal
NCT0036374038
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PHASE3COMPLETED
A Study Of GW685698X For The Treatment Of Perennial Allergic Rhinitis In Pediatrics
Rhinitis, Allergic, Perennial
NCT0011688390
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PHASE3COMPLETED
A Study of GW685698X for the Treatment Of Perennial Allergic Rhinitis in Adolescents and Adults
Rhinitis, Allergic, Perennial
NCT0011681890
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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.
HPA axis function at baseline and after 6 weeks of treatment as measured by 24 hour urine and serial serum cortisol assessments in domiciled subjects

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 to 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 StatesCanada
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Frequently asked questions about GW685698X Aqueous

What is GW685698X Aqueous used for?

GW685698X Aqueous is an investigational small molecule being developed for the treatment of allergic rhinitis, including perennial allergic rhinitis and seasonal allergic rhinitis. It is formulated as an aqueous nasal spray and has been studied in adolescents and adults aged 12 years and older.

Who makes GW685698X Aqueous?

GW685698X Aqueous is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The drug is in Phase 3 clinical development for allergic rhinitis indications.

What phase is GW685698X Aqueous in?

GW685698X Aqueous is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All completed trials for this asset are Phase 3 studies.

What clinical trials is GW685698X Aqueous in?

GW685698X Aqueous has been studied in three completed Phase 3 trials: NCT00116818 for perennial allergic rhinitis, NCT00118729 for seasonal allergic rhinitis onset of action, and NCT00197262 for seasonal allergic rhinitis. A fourth trial, NCT00363740, also studied seasonal allergic rhinitis.

Is GW685698X Aqueous the same as fluticasone furoate?

GW685698X Aqueous is an investigational compound developed by GSK. The data provided does not indicate that it is the same as fluticasone furoate, a marketed corticosteroid nasal spray. No alternative names for GW685698X Aqueous were provided.