CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 301 enrolled
Drug / intervention
FF +1 moredrug
Likely dose
Fluticasone furoate 110 μg intranasal spray once dailyAI-extracted
Key inclusion· 3
  • ✓Confirmed diagnosis of perennial allergic rhinitis (PAR)
  • ✓Age 12 years or older
  • ✓Able to comply with study procedures and literate
Key exclusion· 6
  • ✕Significant concomitant medical conditions
  • ✕Current use of corticosteroids
  • ✕Use of allergy medications or other identified medications during the study
  • ✕Current tobacco use or tobacco use within the past year

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00289198
NCT00289198Phase 3Completed
CompareCT.gov

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)

GlaxoSmithKline·interventional·Posted Feb 9, 2006·Updated Apr 13, 2018

In Brief

A Phase 3 clinical trial evaluating FF and Placebo for Rhinitis, Allergic, Perennial. Completed, enrolled 301 participants across 42 sites in 9 countries.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRhinitis, Allergic, Perennial
CountriesAustralia, Canada, Estonia, Germany, Latvia, Lithuania, New Zealand, Russia, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 9, 2006
Enrollment StartFeb 7, 2006
Primary CompletionJul 1, 2006
Study CompletionJul 4, 2006
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 20.4 years ago

Interventions

FFdrug

fluticasone furoate 110 μg nasal spray

Placebodrug

placebo nasal spray