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GW685698X Aqueous

Phase 3

Rhinitis, Allergic, Perennial | Small molecule | Respiratory |GSK plc|Trials Updated: Aug 31, 2018

GW685698X Aqueous target and mechanism

ModalitySmall molecule

Also known as GW685698X Aqueous Nasal Spray

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials5
Total Enrollment886

FDA Designations

No designations recorded

GW685698X Aqueous clinical trials

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, SeasonalUnlock trial analytics
PHASE3COMPLETED
Study In Adolescent And Adult Subjects 12 Years Of Age And Older With Seasonal Allergic Rhinitis To Assess Onset of Action
Rhinitis, Allergic, SeasonalUnlock trial analytics
PHASE3COMPLETED
Study of GW685698X In Patients With Seasonal Allergic Rhinitis
Rhinitis, Allergic, SeasonalUnlock trial analytics
PHASE3COMPLETED
A Study Of GW685698X For The Treatment Of Perennial Allergic Rhinitis In Pediatrics
Rhinitis, Allergic, PerennialUnlock trial analytics
PHASE3COMPLETED
A Study of GW685698X for the Treatment Of Perennial Allergic Rhinitis in Adolescents and Adults
Rhinitis, Allergic, PerennialUnlock trial analytics

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?

GW685698X Aqueous is an investigational small molecule nasal spray being developed by GSK plc for allergic rhinitis. It is studied in both seasonal and perennial allergic rhinitis, which are nasal allergy conditions triggered by seasonal pollens or year-round allergens. It is in Phase 3 clinical development.

What is GW685698X Aqueous used for?

GW685698X Aqueous is being studied for the treatment of allergic rhinitis, including seasonal allergic rhinitis and perennial allergic rhinitis. Seasonal allergic rhinitis is triggered by pollens such as grass or tree pollen, while perennial allergic rhinitis is triggered by year-round allergens such as dust mites or pet dander.

Who makes GW685698X Aqueous?

GW685698X Aqueous is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical trials evaluating the nasal spray in patients with seasonal and perennial allergic rhinitis.

What phase is GW685698X Aqueous in?

GW685698X Aqueous is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA. All three completed trials were Phase 3 studies, and no active trials are currently listed.

What clinical trials is GW685698X Aqueous in?

GW685698X Aqueous has been evaluated in Phase 3 trials including NCT00363740 in seasonal allergic rhinitis, NCT00197262 and NCT00118729 in seasonal allergic rhinitis, and NCT00116883 in pediatric perennial allergic rhinitis. All four trials are completed, with a combined enrollment of 706 participants.

Is GW685698X Aqueous the same as GW685698X Aqueous Nasal Spray?

Yes, GW685698X Aqueous is also known as GW685698X Aqueous Nasal Spray or GW685698X aqueous nasal spray. These names refer to the same investigational nasal spray product developed by GSK plc for allergic rhinitis.