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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).

Official Title

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 6 Weeks in Adult and Adolescent Subjects 12 Years of Age and Older With Perennial Allergic Rhinitis (PAR)

Conditions

Perennial Allergic Rhinitis

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

  • 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.

Study Start

February 2006

Eligibility & Criteria

  • Ages Eligible for Study: 12 Years and above
  • Genders Eligible for Study: Both

Inclusion Criteria:

  • Diagnosis of perennial allergic rhinitis (PAR).
  • Must comply with study procedures and be literate.

Exclusion Criteria:

  • Significant concomitant medical conditions.
  • Use of corticosteroids.
  • Use of allergy and other identified medications during the study.
  • Current tobacco use or tobacco use within the past year.
  • Exposure to an investigational study drug within the past 12 months.
  • Clinically significant abnormal electrocardiograms (ECG) or laboratory abnormality.

Total Enrolment

288

Contact Details

Australian Locations:

  • Clayton, 3168, Australia
  • Sydney, 2050, Australia
  • Adelaide, 5000, Australia
  • Nedlands, 6009, Australia
  • Kippa Ring, 4021, Australia
  • Melbourne, 3004, Australia
  • Parkway, 3052, Australia

Contact GlaxoSmithKline Australia (Please refer to trial identifier: NCT00289198)

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Dates

Posted On: 1 January, 2013
Modified On: 16 September, 2014

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