A Study To Evaluate The Efficacy And Safety Of A Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR).
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The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with perennial allergic rhinitis (PAR).
Condition or disease
Rhinitis, Allergic, Perennial
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Perennial Allergic Rhinitis (PAR)
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 Years of Age and Older) With Perennial Allergic Rhinitis (PAR)
Mean change from baseline over the entire treatment period in daily, reflective total nasal symptom scores. Subjects complete diaries twice daily (every 12 hours) reporting the severity of their PAR symptoms.
Secondary Outcome Measures
Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous total nasal symptom scores. The subject completes an overall evaluation of response to therapy during the last clinic visit.
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Ages Eligible for Study:
12 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Diagnosis of perennial allergic rhinitis (PAR).
Must comply with study procedures and be literate.
Significant concomitant medical conditions.
Use of corticosteroids.
Use of allergy medications and some other medications during the study.
Current tobacco use.
Clinically significant abnormal ECG or laboratory abnormality.
Nathan R, Berger W, Yang W, Cheema A, Silvey MJ, Wu W, Faris M, Philpot E. Once daily fluticasone furoate* nasal spray (FFNS), a novel enhanced affinity steroid, provides 24-hour relief for the nasal symptoms of perennial allergic rhinitis (PAR) J Allergy