NCT02424539

A Study to Compare the Efficacy and Safety of Fluticasone Furoate Nasal Sprays (FFNS) 55 Microgram (mcg) and 110 mcg in Chinese Pediatric Subjects With Allergic Rhinitis (AR)

A Randomized, Doubled-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of Fluticasone Furoate Nasal Spray 55 mcg and 110 mcg for 4 Weeks in Chinese Pediatric Subjects Ages 2 to 12 Years With Allergic Rhinitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 358 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

This Phase IV interventional study is a multi-center, randomized, double-blind, placebo-controlled parallel study to evaluate the efficacy and safety of FFNS110 mcg and 55 mcg once daily versus vehicle placebo aqueous nasal spray in chinese pediatric subjects ages 2 to 12 years with AR. This study comprises screening and run-in period (4 to14 days), double-blind treatment period (28 days) and follows up period (3 to7 days). Subjects entering the study will participate for maximum of 50 days, including five clinical visits and a follow-up contact. The study is planned to enroll approximately 360 subjects.

Conditions

• Rhinitis, Allergic, Perennial and Seasonal
• Rhinitis, Allergic

Interventions

Type	Name	Description
DRUG	FFNS	FF as a aqueous suspension for intranasal inhalation with unit dose strength of 27.5 mcg per dose administered via a metered side-actuated nasal spray device.
OTHER	Placebo	Placebo as a aqueous suspension to match the other study treatments minus the active component(s) for intranasal inhalation administered via a metered side-actuated nasal spray device.

Timeline

• Start date: 2015-09-30
• Primary completion: 2017-10-25
• Completion: 2017-10-25
• First posted: 2015-04-23
• Last updated: 2021-01-11
• Results posted: 2019-02-06

Locations

16 sites across 1 country: China