At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 61 enrolled
Drug / intervention
Fluticasone furoatedrug
Likely dose
Fluticasone furoate 55 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Study FFR116365, an Open-label Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis
In Brief
A Phase 3 clinical trial evaluating Fluticasone furoate for Rhinitis. Completed, enrolled 61 participants across 6 sites.
Detailed Summary
Safety of GW685698X (55 µg/day, q.d.) nasal spray over a period of 12 weeks in Japanese paediatric subjects ages 2 to \< 15 years with perennial allergic rhinitis will be evaluated. And secondarily, efficacy and systemic exposure of GW685698X (55 µg/day, q.d.) nasal spray over a period of 12 weeks in Japanese paediatric subjects ages 2 to \< 15 years with perennial allergic rhinitis will also be evaluated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRhinitis
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2012
First PostedJun 2012
Primary CompletionNov 2012
TodayJul 2026
First PostedJun 19, 2012
Enrollment StartJun 1, 2012
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 14.0 years ago
Interventions
Fluticasone furoatedrug
55 mcg/day, intranasal, 12 weeks